[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peri-menopausal-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peri-menopausal-women":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"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":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641443","hydration--female-life-stages-100641443",false,"NCT07653620","Hydration & Female Life Stages","Effect of Female Life Stage on Rehydration With Water vs. an Electrolyte Solution After Overnight Fast\u002FFluid Restriction","Inclusion Criteria:\n\n* • Sex assigned female at birth.\n\n  * Recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)\n  * Age 18-60 years, within the following life stage ranges specified below:\n  * Premenopausal:\n\n    * 18-35 years\n    * Self-report regular spontaneous menstrual cycle length (21-35 days) for the past 2 menstrual cycles\n    * Menstrual cycle length \\\u003C 7 days variation in consecutive cycles\n  * Perimenopausal:\n\n    * Perimenopause: 35-55 years\n    * If tracking cycles: self reported cycle irregularity (≥7 day difference from usual cycle length) for the past 2 menstrual cycles, not due to known pathology\n    * If not tracking cycles: clinician diagnosis\n  * Postmenopausal:\n\n    * Postmenopause: 45-60 years\n    * If tracking cycles: ≥12 consecutive months of spontaneous amenorrhea not due to pregnancy, lactation, or pathology\n    * If not tracking cycles: clinician diagnosis\n  * Healthy, with no known renal, cardiovascular, metabolic, or endocrine disorders that affect hydration or fluid regulation.\n  * Not currently taking medications known to influence fluid balance (e.g., diuretics, laxatives, weight loss agents, or other relevant medications) or the hypothalamus-pituitary-gonadal axis (e.g., ovulation induction agents, gonadotropins, IVF stimulation medications, or other relevant medications)\n\n    o See appendix 13.8 for list of medications, drugs, and\u002For medical conditions that may impair cognitive functioning, alter physiological responses relevant to the study outcomes, or increase the risk associated with participation.\n  * Not receive any fertility treatments within the past 6 months\n  * No hormonal contraceptives use within the past 6 months\n  * If using a paraguard copper IUD, it must be inserted for ≥ 3 months (if applicable)\n  * BMI ≤ 30 kg\u002Fm²\n  * Are not participating in a weight loss program\n  * Are not allergic to adhesives, stevia, and strawberry lime flavoring\n  * Willing to avoid strenuous activity and alcohol consumption 24 hours prior to all visits\n  * Willing to fast overnight (\\~12 hours) prior to the medical screening\n  * For visit 2 and 4:\n\n    * Willing to fast overnight (\\~12 hours)\n    * Willing to consume a minimum of 2.7 L of water 24 hours prior to visits 2 and 4, then 500 mL 2 hours before the start of the visits 2 and 4\n  * For visits 3 and 5:\n  * Willing to restrict all fluids (\\~18 hours)\n  * Willing to limit fluid consumption to 1 L the morning\u002Fafternoon prior to the start of the fluid restriction\n  * Willing to restrict food (\\~12 hours) the day prior to each visit Willing to eat a consistent diet the day prior\n  * Fluent in English (able to read, understand, and provide informed consent).\n  * Willing and able to provide informed consent to participate in the study and comply with all study procedures and scheduled visits\n\nExclusion Criteria:\n\n* • Currently pregnant or breastfeeding\n\n  * \\\u003C 6 months since giving birth (even if experiencing 2 regular menstrual cycles in a row)\n  * Smoking within the last 5 years\n  * History of adverse events (e.g., fainting) with blood draws\n  * Participants with large amount of internal metal (e.g., spinal rod) will be excluded from the DXA scan only (Brandenton)\n  * Participant has participated in a clinical trial within the past 30 days\n  * Participant has participated in any PepsiCo trial within past 3 months\n  * Participant has a condition or is taking medication that the investigator believes would interfere with his\u002Fher ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk\n  * Participant is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If participant is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.",true,"FEMALE","18 Years","60 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","Female life stages including premenopausal, perimenopausal, postmenopausal, are characterized by changing concentrations and patterns of hormones. The premenopause stage represents the reproductive years with normal menstrual cycles lasting between 21-35 days. The perimenopause stage is the beginning of the menopause transition and can last up to 10 years. During this transition, menstrual cycles become longer and irregular in length (7 days or longer). After 12 consecutive months with no period, the transition is complete into the postmenopause stage.\n\nHormones that change across the lifespan are known to influence systems that regulate thirst, fluid balance, and sodium balance. Yet, fluid balance across life stages remains poorly understood, with no direct comparisons across all three life stages. The purpose of this study is to evaluate the effect of female life stage on rehydration with water and electrolyte solution after overnight fast and fluid restriction",[28,29,30,31,32,33],"Dehydration","Menstruation","Pre-menopause","Peri-menopausal Women","Post-menopausal Women","Hydration","RECRUITING","2026-06-12",{"date":37,"type":38},"2026-06-17","ACTUAL",{"date":40,"type":22},"2026-06",{"date":42,"type":22},"2026-12",{"name":44,"class":45},"PepsiCo Global R&D","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100623880","effects-of-amylopectin-chromium-blend-on-whole-body-protein-kinetics-and-glucose-in-peripost-menopausal-women-100623880","NCT07402382","Effects of Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose in Peri\u002FPost-Menopausal Women","Effects of an Amylopectin Chromium Blend on Whole-Body Protein Kinetics and Glucose Control in Peri\u002FPost-Menopausal Women","Inclusion Criteria:•\n\nWomen aged 40-65 years who meet either of the following menstrual-history criteria:\n\n* ≥ 60 days but \\\u003C 12 months of amenorrhea (late perimenopause)\n* Women with ≥ 12 months of spontaneous amenorrhea (post-menopausal)\n\n  * No more than 3 days per week of structured physical activity\n  * Provide voluntary signed and dated informed consent.\n  * Be in good health and able to participate in an exercise bout as determined by assessment, medical history, and routine blood chemistries.\n  * Between the of 40 and 65 years of age (inclusive).\n  * Body Mass Index of 18.5-34.9 (inclusive).\n  * Body weight of at least 110 pounds.\n  * Normotensive (seated, resting systolic blood pressure \\\u003C140 mm Hg and diastolic blood pressure \\\u003C 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.\n  * Normal supine, resting heart rate (\\\u003C90 per minute).\n  * Subject agrees to follow standardized controlled diet for 3 days and maintain existing dietary patterns on other days throughout the study period.\n  * Subject is willing and able to comply with the study protocol.\n  * Able to provide an adequate blood draw.\n  * If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study. Note: A generic multivitamin is allowed.\n  * Refrain from caffeine, exercise, and alcohol for 24 hours prior, and fast for 10 hours prior to each visit.\n\nExclusion Criteria:\n\n* Current use of any dietary ingredient that impacts glucose control or insulin sensitivity.\n* Current vegans or vegetarians.\n* Intolerance to dairy foods\u002Fdrinks.\n* Smokes more than 10 cigarettes per day or uses other nicotine products (i.e. vape, patch) that deliver a similar amount of nicotine.\n* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).\n* Prior gastrointestinal bypass surgery (Lapband, etc.).\n* Individuals using any kind of GLP-1 medications.\n* Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).\n* Individuals who have gained or lost more than 10 pounds within the last 30 days.\n* Individuals who are cognitively impaired and\u002For who are unable to give informed consent.\n* Chronic medically diagnosed inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV\u002FAIDS, etc.).\n* Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.\n* Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.\n* Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.","40 Years","70 Years",{"count":57,"type":22},60,[25],"The goal of this study is to better understand how an amylopectin chromium blend may influence whole body protein balance in women during midlife, when hormonal changes can adversely affect protein metabolism and muscle maintenance. Continuous glucose monitoring will also be used to assess glycemic control over a 24-hour period.\n\nThe main questions the study aims to answer are:\n\n* Does the use of an amylopectin chromium blend in peri- and post-menopausal women help to support positive protein balance\n* Can the affect be achieved using a concentrated dose\n\nResearchers will compare the nutritional supplement to a placebo (amylopectin alone) to see if the amylopectin chromium blend can promote positive protein balance. A concentrated dose of the supplement will also be evaluated for comparative effectiveness.\n\nParticipants will:\n\n* Consume the nutritional supplement (standard or concentrated dose) or placebo acutely after a short resistance exercise bout\n* Complete four in-person visits, including the single-day intervention\n\nResults from this research may help guide future nutritional strategies to support healthy aging, muscle function, and overall metabolic health.",[61,62,31,63],"Glucose Monitoring, Continuous","Whole Body Protein Metabolism","Post-menopause",[65,66],"Glucose","protein metabolism","2026-04-06",{"date":69,"type":38},"2026-04-13",{"date":71,"type":38},"2025-11-01",{"date":73,"type":22},"2026-09-30",{"name":75,"class":45},"Nutrition 21, Inc.",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100620756","qualia-perimenopause-efficacy-and-tolerability-study-an-open-label-3-arm-trial-100620756","NCT07361757","Qualia Perimenopause Efficacy and Tolerability Study: An Open-label 3-Arm Trial","Inclusion criteria:\n\n1. Provide voluntary, written, informed consent to participate in the study\n2. Agree to provide a valid cell phone number and are willing to receive communications through text\n3. Can read and write English\n4. Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly\n5. Willing to complete questionnaires, records, and diaries associated with the study\n6. Healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months)\n7. MRS total score ≥ 5 (preference given to higher score)\n\nExclusion criteria:\n\n1. Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial\n2. Known food intolerances\u002Fallergy to any ingredients in the product\n3. Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer\n4. Having had a significant cardiovascular event in the past 6 months\n5. Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines\n6. On immunosuppressive therapy\n7. Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months\n8. Adults lacking capacity to consent\n9. Post-menopause (≥12 consecutive months without a period)\n10. Taking medications: hormone replacement therapy; oral contraceptives; selective estrogen receptor modulators\u002Faromatase inhibitors (e.g., Tamoxifen); sedatives\u002Fanxiolytics; blood thinners; insulin","55 Years",{"count":85,"type":22},120,[25],"This is an open-label, 3-arm clinical trial evaluating the short-term efficacy and tolerability of Qualia Perimenopause-a multi-ingredient dietary supplement formulated to support perimenopausal symptoms-in healthy women aged 40-55 who are symptomatic but not yet menopausal (menses within the past 12 months). Approximately 120 participants will be allocated across three parallel arms and will take 1 capsule once daily for 28 consecutive days. The primary outcome is between-group change from baseline to day 28 in menopause symptom burden measured by the total Menopause Rating Scale (MRS). Secondary outcomes include within- and between-group changes at days 14 and 28 in cognitive function (PROMIS Cognitive Function v2.0 - Short Form 8a), sleep disturbance (PROMIS), MRS subdomains (psychological, somato-vegetative, urogenital), overall MRS change, safety\u002Ftolerability (custom survey), and participant-reported product experience. All assessments are completed electronically at home at baseline, mid-intervention (day 14), and end-of-study (day 28), with a brief follow-up questionnaire; there are no in-person visits.",[31],"NOT_YET_RECRUITING","2026-01-15",{"date":92,"type":38},"2026-01-23",{"date":94,"type":22},"2026-02-01",{"date":96,"type":22},"2026-04-30",{"name":98,"class":45},"Qualia Life Sciences"]