[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-health":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,57,87,117,148,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100588793","effect-of-a-fermented-dairy-protein-with-prebiotic-fiber-on-gi-complaints-100588793",false,"NCT06946017","Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints","Effect of a Fermented Whey and Fiber Supplement on Digestive Comfort of Recreational Athletes With and Without GI Complaints","Aside from having participants fitting the inclusion and exclusion criteria below, potential participants will be screened using the gastrointestinal symptom rating scale (GSRS). Based on the outcome they will be assigned to the Part I (i.e. no self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with all items scored \\\u003C4 (severe) and a total GSRS score ≤25), or Part II (i.e. Severe self-reported GI tract issues (GSRS questionnaire score GI complaints, based on GSRS screening with at least one item scored ≥4 (severe) and a total GSRS score ≥30). If they don't fit these criteria (i.e., having a GSRS score ranging from 26-29) they will be excluded from participation.\n\nInclusion Criteria:\n\n* Healthy subjects living in the Phoenix area in AZ, USA during the study\n* Women\u002FMen aged between 18-50 years (50-50%)\n* Recreational competitive and non-competitive athletes (exercise at least 2x per week with a minimal total duration of 2 hours\u002Fweek)\n* BMI value between ≥18.5 and ≤ 30 kg\u002Fm2\n* No physical limitations due to an injury (i.e., able to perform all activities associated with daily living and exercise in an independent manner).\n* Willing to slightly increase their energy intake via a supplement during the study period on daily basis in the morning before breakfast.\n* Willing and comfortable to perform multiple physical (stress) tests on a treadmill during the study.\n* Participants without any contraindications when scoring the Physical Activity Readiness Questionnaire (PAR-Q+).\n* Written informed consent\n* For part I: Self-perceived lactose intolerance, and\u002For omission of dairy products, and\u002For identifying as Hispanic\u002FLatino or Asian\n* For part I: Determined to be lactase non-persistent (LNP) CC genotype by qPCR, and\u002For positive lactose intolerance test (\\>20ppm increase from baseline when 25g of lactose administered)\n\nExclusion Criteria:\n\n* Users of (sport) supplements containing probiotics and\u002For prebiotics and those unwilling to temporarily stop use of these supplements at least 3 weeks prior to start of the intervention\n* Women who plan to start or stop the use of contraceptives before or during study period\n* Women that have additional or worse GI symptoms during their period that can be classified as severe\n* Smoking\n* Clinical lactose intolerance\n* Clinical or self-perceived milk protein allergy\n* Diagnosed GI tract disorders or diseases\n* Musculoskeletal disorders\n* Diagnosed metabolic disorders (such as diabetes)\n* Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).\n* Chronic use of gastric acid suppressing medication or anti-coagulants\n* Chronic use of anti-inflammatory medication\n* Use of antibiotics the past 0-6 months\n* Blood donation in the past 2 months\n* (Intending to become) Pregnant\u002Flactating women\n* Significant changes in body weight during the past 4 weeks (i.e., due to reduction of body weight through limiting caloric intake, illness,)\n* Athletes should not aim to lose bodyweight by reducing energy intake during the study\n* For Part I: A hydrogen breath peak of less than 20 ppm over baseline during a lactose tolerance test",true,"ALL","18 Years","50 Years",{"count":21,"type":22},114,"ESTIMATED","INTERVENTIONAL",[25],"NA","A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections.\n\nPart I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period).\n\nPart II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).",[28,29],"Digestive Health","Quality of Life",[31,32,33,34,35,36,37,38,39,40,41,42,43],"Participants","Healthy subjects","Athlete","Women","Men","Fermented Dairy","Prebiotics","Gut microbiota","Self-reported","GI-tract","Diet","Immune markers","Exercise","RECRUITING","2026-05-06",{"date":47,"type":48},"2026-05-08","ACTUAL",{"date":50,"type":48},"2025-03-31",{"date":52,"type":22},"2027-06-30",{"name":54,"class":55},"Arizona State University","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":56},"100632661","study-to-investigate-the-efficacy-of-a-digestive-health-dietary-supplement-on-post-meal-bloating-in-healthy-participants-100632661","NCT07516587","Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants","A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Safety and Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants","Inclusion Criteria:\n\n* Healthy male and female individuals aged 18-65 years at time of screening.\n* Body mass index (BMI) \\\u003C29.9 kg\u002Fm².\n* Self-reported recurrent postprandial abdominal bloating and\u002For distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.\n* Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.\n* Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.\n* Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points.\n* Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.\n* Provides voluntary, written, informed consent to participate in the study prior to any study procedures.\n* Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.\n\nExclusion Criteria:\n\n* Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.\n* Significant or untreated medical and\u002For psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.\n* Current use of digestive enzyme supplements, prebiotics\u002Ffibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (\\>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.\n* Esophageal obstruction or difficulty swallowing.\n* Wear dentures.\n* Pregnant, breastfeeding, or planning to become pregnant during the study.\n* Known allergy, or sensitivity to any ingredient of the study supplement or placebo, including ginger, lemon balm, dandelion, or Bifidobacterium longum-derived products.\n* Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of standardized meal ingredients.\n* Alcohol use disorder or drug abuse\u002Fdependence within the past 6 months (\\>2 standard drinks\u002Fday on average).\n* Currently following an extremely restrictive diet or having done so within the past 3 months.\n* Participation in another clinical research trial within 30 days prior to randomization.\n* Cognitively impaired or unable to provide informed consent.\n* Any other condition that, in the Investigator's opinion, may adversely affect the participant's ability to complete the study or its measures, or that may pose significant risk to the participant.","65 Years",{"count":66,"type":22},100,[25],"The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.",[28,70,71],"Abdominal Discomfort","Gas and Bloating",[73,74,75,76],"bloating","abdominal distension","Arrae","intestinal gas","NOT_YET_RECRUITING","2026-04-07",{"date":80,"type":48},"2026-04-13",{"date":82,"type":22},"2026-04",{"date":84,"type":22},"2026-10",{"name":75,"class":86},"INDUSTRY",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":56},"100625358","an-8-week-study-evaluating-gut-and-digestive-health-after-use-of-a-dietary-supplement-system-100625358","NCT07421596","An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System","An Eight-week Clinical Study for the Measurement of Gut and Digestive Health Parameters Before and After the Use of a Dietary Supplement System","Inclusion Criteria:\n\n* 1\\. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening.\n\n  2\\. Willing and able to provide written informed consent before participation in any study-related procedures.\n\n  3\\. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.\n\n  4\\. Willing to collect and provide stool samples, either in-clinic or at home as instructed.\n\n  5\\. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.\n\n  6\\. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone.\n\n  8\\. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.\n\n  9\\. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol.\n\n  11\\. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.\n\n  2\\. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to:\n  * Malabsorption disorders\n  * Chronic gastrointestinal diseases\n  * Severe depression\n  * Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report.\n\n    4\\. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception.\n\n    5\\. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment.\n\n    8\\. History of weight loss surgery or any type of bowel surgery, including resection or colectomy.\n\n    9\\. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.\n\n    10\\. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.\n\n    11\\. History of seizure disorder or use of seizure medication within the past 4 weeks.\n\n    12\\. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to:\n  * Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)\n  * Laxatives or gastrointestinal motility agents\n  * Medications for irritable bowel syndrome (IBS), Crohn's disease, or history of hospitalized diverticulitis 14. Any other condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation or compromise subject safety or study integrity.","80 Years",{"count":96,"type":22},50,[25],"This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period.\n\nGut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being.\n\nIn this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires.\n\nStool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being.\n\nThe study will also monitor the safety and tolerability of the dietary supplement system during the study period.",[100,28,101],"Gastrointestinal Symptoms","Gut Health",[103,104,105,106],"Stool biomarkers","Probiotics","Subjective digestive health","Gut Zoomer stool test","2026-02-22",{"date":109,"type":48},"2026-02-24",{"date":111,"type":22},"2026-02-05",{"date":113,"type":22},"2026-04-21",{"name":115,"class":116},"SF Research Institute, Inc.","NETWORK",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":56},"100603897","effects-of-omeprazole-ingestion-on-postprandial-amino-acid-concentrations-in-response-to-a-mixed-meal-100603897","NCT07142486","Effects of Omeprazole Ingestion on Postprandial Amino Acid Concentrations in Response to a Mixed Meal","Effects of Omeprazole Ingestion on Postprandial Amino Acid Concentrations in Response to a Mixed Meal: A Pilot Study","Inclusion Criteria:\n\n1. Healthy adult female or male participants who are 50 to 60 years of age at screening (inclusive)\n2. Has a BMI between 18.5 to 29.9 kg·m-2 (inclusive) at screening visit\n3. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and able to consume the study product\n4. Has maintained stable use of medication and supplements stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study\n5. Agree to avoid strenuous exercise 48 h prior to each study visit\n6. Willing to limit daily alcohol consumption to no more than 3 standard drinks per day throughout the study, and agree to entirely avoid alcohol consumption 48 h prior to each visit (a standard serving is defined here as 4 oz wine, 12 oz beer, 1 oz spirits)\n7. Willing to maintain current use of cannabinoids (if applicable) throughout the study\n8. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.\n\nExclusion Criteria:\n\n1. Individuals who are lactating, pregnant or planning to become pregnant during the study\n2. Individuals who adhere to a diet (e.g., vegan diet) that restricts consumption of dairy products\n3. Has a known sensitivity, intolerability, or allergy to any of the study products or their excipients (i.e., lactose intolerant)\n4. Weight loss or gain \\> 3 kg in the 3 months prior to study visit 1\n5. Currently or planning to be on a weight loss regimen during the study\n6. Received a vaccine for COVID-19 in the two weeks prior to screening or plans to receive a vaccine for COVID-19 during the study period, currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit, or currently has any post COVID-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis)\n7. Recent (within 2 weeks of screening visit) history of an episode of acute GI illness such as nausea\u002Fvomiting or diarrhea\n8. Have a history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery\n9. Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and\u002For digestion (e.g., history of bowel obstruction)\n10. Participated in upper gastrointestinal endoscopy and\u002For colonoscopy or preparation within 3 months prior to screening visit\n11. Diagnosed with hypercholesterolemia or hypertriglyceridemia (i.e., elevated fasting low-density lipoprotein (LDL) (≥ 135 mg·dL-1; ≥ 3.5 mmol·L-1) or elevated triglycerides (≥ 150 mg·dL-1; ≥1.7 mmol·L-1)\n12. Has a history of heart disease\u002Fcardiovascular disease, uncontrolled hypertension (≥ 140 systolic or ≥ 90 diastolic mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease\n13. Is Type I or Type II diabetic or pre-diabetic \\[i.e., elevated fasting blood glucose levels (≥ 100 mg·dL-1; ≥ 5.6 mmol·L-1) and\u002For elevated hemoglobin A1c (≥ 6.0%)\\]\n14. Has a history of liver or gallbladder disease or stomach ulcers\n15. Has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorders and\u002For immunocompromised (e.g., HIV\u002FAIDS)\n16. Diagnosed with cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study\n17. Major surgery in 3 months prior to screening or planned major surgery during the study\n18. History of alcohol or substance abuse (including cannabinoids) in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program)\n19. Receipt or use of test products in another research study within 30 days prior to study visit 1 or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study\n20. Current or previous tobacco use within the last 6 months\n21. Self-report of blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to screening or a blood donation of more than 450 mL within 56 days prior to baseline\n22. Self-report of donating plasma (e.g., plasmapheresis) within 14 days prior to screening.\n23. Any other active or unstable medical conditions or use of medications, supplements, or therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.","60 Years",{"count":126,"type":22},4,[25],"Omeprazole is a proton pump inhibitor commonly used to reduce stomach acid in the treatment of heartburn, gastroesophageal reflux disease, and gastric ulcers. By blocking the H⁺\u002FK⁺-ATPase pumps in the gastric lining, it raises gastric pH and can alter the normal activation of pepsin, the enzyme responsible for beginning protein breakdown in the stomach.\n\nUnder normal conditions, dietary proteins are denatured by gastric acid and cleaved by pepsin into smaller peptides. These peptides enter the small intestine, where pancreatic enzymes (trypsin, chymotrypsin) and brush-border peptidases (aminopeptidase, dipeptidase) further hydrolyze them into free amino acids that are absorbed into the bloodstream. Suppressing stomach acidity may allow larger peptides to pass into the intestine, potentially reducing the efficiency of amino acid liberation and absorption.\n\nIn this randomized, crossover study, adults aged 50-60 years will attend two study visits at least one week apart. In one visit they will take a standard dose of omeprazole before consuming a mixed meal with a fixed protein content; in the other visit they will consume the same meal without medication. Blood samples will be collected before the meal and at multiple time points afterward to measure plasma amino acid concentrations and compare postprandial responses.\n\nOlder adults experience anabolic resistance, meaning they require higher protein intakes to stimulate muscle protein synthesis effectively. If omeprazole reduces amino acid availability after a meal, individuals taking this medication may need adjusted dietary protein recommendations. Findings from this study will help refine nutrition guidelines for people on proton pump inhibitors and support optimal muscle health and recovery in middle-aged and older adults.",[28,130],"Gastrointestinal Health",[132,133,134,135,136,137,138,139],"Aminoacidemia","Omeprazole","Mixed Meal","Healthy Adults","Postprandial","Protein","Proton Pump Inhibitor","PPI",{"date":141,"type":48},"2026-02-06",{"date":143,"type":48},"2025-09-01",{"date":145,"type":22},"2026-03",{"name":147,"class":55},"McGill University",{"id":149,"slug":4,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":154,"minAge":18,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":167,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":175,"leadSponsor":177,"locationsCount":56},"100613801","NCT07271316","Alii Supplement Study","Birth Control Supplement Study","Inclusion Criteria:\n\n* Participants must be on the hormonal birth control pill as the investigators are testing the effectiveness of a supplement for women who take the hormonal birth control pill\n* Participants must be willing to complete a follow up survey as this study will be multiple parts\n* Participants must be willing to take a daily supplement as this study is testing how a supplement influences a variety of psychological outcomes\n* Participants must be on the hormonal birth control pill for at least six months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet\n* If the investigators are able to do so, the investigators will only recruit participants who take the one-month hormonal birth control pill rather than the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle.\n* Participants must have no food or medication allergies that will prevent the participants from safely taking the supplement\n* Participants must not be taking any vitamins or participant must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control\n* If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible.\n\nExclusion Criteria:\n\n* Participants cannot be naturally cycling as the investigators are testing a supplement for women on hormonal birth control\n* Participants cannot be unwilling to complete a follow up study because this is a multi-part study\n* Participants cannot be unwilling to take a supplement because the study centers around taking a supplement\n* Participants cannot be on the hormonal birth control pill for less than 6 months as participants who have been on the pill for less than 6 months may not be experiencing nutritional depletion yet\n* If the investigators are able to do so, participants cannot take the three month hormonal birth control pill, as the investigators are going to have participants come in after 28 days (day 2 of pack 1 and day 2 of pack 2) and participants on the three-month HBC pill may be on a 21 day cycle.\n* Participants cannot have any food or medication allergies that will prevent the participants from safely taking the supplement\n* Participants must not be taking any vitamins or participants must report willingness to abstain from taking vitamins during the study as individuals who are already taking vitamins may not be experiencing nutritional depletion associated with hormonal birth control\n* If the investigators have the ability to do so, the investigators will only recruit participants who are not taking medications. Participants on various medications (e.g., SSRIs, ADHD medications, etc.) may report differing psychological states due to their medications, rather than the supplement. Therefore, it would be best to exclude those individuals if possible.","FEMALE","25 Years",{"count":157,"type":22},68,[159],"PHASE2","The goal of this clinical trial is to learn if the Alii Supplement can be used to reduce symptoms related to nutritional depletion in hormonal birth control pill users. The main questions it aims to answer are:\n\nDoes usage of the supplement increase happiness, decrease perceived vulnerability to disease, increase digestive health, decrease mood swings, and increase energy?\n\nThe investigators will compare the Alii Supplement to a placebo (a capsule that contains no drug) to see if the Alii Supplement works to reduce symptoms associated with nutritional depletion.\n\nParticipants will:\n\nTake the placebo or Alii Supplement everyday for 28 days and visit the research office twice to fill out an online survey comprising of items examining the main outcome measures.",[162,163,28,164,165,166],"Nutrient Deficiency","Happiness","Vulnerability to Disease","Mood Swings","Energy",[168,169,170],"Hormonal Birth Control","Nutritional Depletion","Dietary Supplement","2026-01-12",{"date":173,"type":48},"2026-01-14",{"date":171,"type":48},{"date":176,"type":22},"2026-04-29",{"name":178,"class":55},"Texas Christian University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":204,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100552680","m4c-nutraceutical-intervention-human-health-effects-pilot-100552680","NCT06476236","M4C Nutraceutical Intervention Human Health Effects Pilot","M4C Pilot","Inclusion Criteria:\n\n* Healthy adults\n\nExclusion Criteria:\n\n* amputation\n* blood clotting disorder\n* metal implants or implanted electrical device(s)\n* known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension\n* inability to fast i.e. low blood sugar\n* pregnant or may be pregnant during the course of the study\n* amino acid metabolizing disorder i.e. phenylketonuria\n* severe edema\n* did not pass screening criteria as determined by MRI facility\n* allergies\u002Fintolerance to any nutraceutical ingredients: amino acids, vitamins, minerals, tapioca starch, sunflower lecithin, stevia, limes or fatty acids like docosahexaenoic acid",{"count":187,"type":22},20,[25],"This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle\u002Ffat\u002Fwater composition), and metabolite\u002Fnovel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.",[191,192,193,194,28,195,196,197,198,199,200,201,202,203],"General Health and Wellness","Energy and Vitality","Cognitive Function and Mental Health","Weight Management","Exercise Tolerance","Cardiovascular Health","Bone and Joint Health","Skin, Hair, and Nail Health","Immune Support","Sports Performance and Recovery","Sleep and Relaxation","Obesity","Anti Inflammatory",[191,192,193,194,28,195,196,197,198,199,200,205,202,206],"Sleep and relaxation","anti inflammatory","2024-06-24",{"date":209,"type":48},"2024-06-26",{"date":211,"type":22},"2024-06-17",{"date":213,"type":22},"2025-06-17",{"name":215,"class":55},"Concordia University Wisconsin"]