[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"supplementation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:supplementation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,84,110,146,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100631698","effects-of-physical-exercise-and-a-nutritional-supplement-on-body-composition-metabolic-function-and-overall-health-in-adults-with-a-metabolically-challenging-profile-100631698",false,"NCT07504068","Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile","Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile.","Inclusion Criteria: Individuals will be eligible to participate in the study if they meet all of the following criteria:\n\n1. Age: Between 50 and 65 years at the time of screening.\n2. Weight status (non-obese): Body mass index (BMI) between 25.0 and 29.9 kg\u002Fm² (overweight range, without clinical obesity).\n3. Metabolically challenged profile (non-obese): Presence of at least two of the following criteria, in addition to the specified BMI range:\n\n   A) Altered body composition (primary criterion): Body fat percentage ≥ 30% in women or ≥ 25% in men, assessed by DXA.\n\n   B) Borderline metabolic markers (one or more):\n   * Fasting glucose: 100-125 mg\u002FdL\n   * Triglycerides: ≥ 150 mg\u002FdL\n   * HDL cholesterol: \\\u003C 50 mg\u002FdL in women or \\\u003C 40 mg\u002FdL in men\n   * LDL cholesterol: ≥ 130 mg\u002FdL\n\n   C) Sedentary lifestyle:\n\n   Low or very low physical activity level, defined as ≤ 600 MET·min\u002Fweek according to the IPAQ questionnaire.\n4. Clinical and functional status:\n\n   * Clinically stable condition, without acute disease or recent decompensation.\n   * Ability to perform moderate-intensity exercise three times per week, according to medical assessment.\n5. Previous treatment and lifestyle:\n\n   * No participation in structured exercise programs (≥ 2 days\u002Fweek) during the previous 6 months.\n   * No intensive hypocaloric diets or medical weight-loss treatments during the previous 3 months.\n6. Administrative and ethical aspects:\n\n   * Ability to understand study explanations and follow instructions.\n   * Signed informed consent prior to initiation of any study procedures.\n\nExclusion Criteria: Individuals presenting any of the following conditions will be excluded from the study:\n\n1. Clinical obesity or anthropometric extremes:\n\n   * BMI ≥ 30.0 kg\u002Fm² (obesity).\n   * Any weight-related or clinical condition that, in the judgment of the principal investigator, contraindicates participation.\n2. Relevant or uncontrolled chronic diseases:\n\n   * Previous diagnosis of type 1 or type 2 diabetes mellitus.\n   * Moderate or severe cardiovascular disease (e.g., ischemic heart disease, heart failure, uncontrolled clinically significant arrhythmias).\n   * Moderate or severe renal, hepatic, or respiratory disease.\n   * Neurological or musculoskeletal disorders limiting or contraindicating the prescribed exercise program.\n3. Pharmacological treatments interfering with energy metabolism or body weight:\n\n   Current use (or use within the previous 3 months) of:\n   * Weight-loss medications or GLP-1 receptor agonists\n   * Systemic corticosteroids at moderate or high doses\n   * Thyroid hormones at non-replacement doses\n   * Anabolic agents or other drugs significantly affecting body composition\n4. Specific prior supplementation: Use of capsaicin, phenylcapsaicin, or other thermogenic or appetite-modulating supplements within the previous 3 months.\n5. Functional or cognitive limitations:\n\n   * Cognitive, psychiatric, or mental health disorders that may impair study comprehension or protocol adherence.\n   * Physical limitations preventing safe participation in exercise.\n6. Substance use:\n\n   * Alcohol consumption at levels considered high risk (\\> 20 g\u002Fday).\n   * Heavy smoking (\\> 10 cigarettes\u002Fday), unless deemed clinically stable by the investigator.\n7. Other exclusion criteria:\n\n   * Concurrent participation in another clinical trial or interventional study.\n   * Any other condition that, in the judgment of the principal investigator, may pose additional risk to the participant or significantly interfere with study outcomes.","ALL","50 Years","65 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","Early-onset metabolic disturbances (such as mild hyperglycemia, subclinical dyslipidemia, excess body fat, and reduced functional capacity) represent one of the major public health challenges among middle-aged and older adults. Although body mass index (BMI) remains the primary clinical criterion for classifying excess weight, growing evidence indicates that BMI does not adequately discriminate cardiometabolic risk, particularly in individuals classified as overweight who present elevated body fat levels (Wu et al., 2024).\n\nSeveral studies have identified altered metabolic phenotypes that do not meet the criteria for obesity, including the so-called \"metabolically unhealthy normal weight\" (MUNW) or \"metabolically unhealthy non-obese\" phenotypes. These individuals are characterized by excess body fat, central adiposity, and alterations in glucose and lipid metabolism despite having a non-obese BMI (Stefan, 2020). This profile is associated with increased insulin resistance, low-grade systemic inflammation, and elevated cardiovascular risk, underscoring the need for targeted interventions in \"metabolically challenged\" individuals. Xiong et al. (2024) demonstrated that metabolic health status independently predicts cardiovascular risk, even when BMI is within non-obese ranges. This evidence supports the rationale of the present project: to intervene in a group of adults without clinical obesity (BMI \\\u003C 30 kg\u002Fm²) but presenting at least two indicators of mild metabolic dysfunction.\n\nNutritional supplements with thermogenic properties that promote fat oxidation and satiety-such as phenylcapsaicin, an analog of capsaicin designed to improve bioavailability and reduce pungency, thereby enhancing tolerability in adults-may offer a promising complementary strategy. Recent studies have shown that low doses of phenylcapsaicin were sufficient to increase fat oxidation during exercise, reduce respiratory exchange ratio, and lower maximal heart rate during submaximal testing compared with placebo (Jiménez-Martínez et al., 2023a). Furthermore, additional research reported that phenylcapsaicin improved strength performance, reduced perceived exertion, and attenuated markers of muscle damage following resistance training (Jiménez-Martínez et al., 2023b). These findings suggest that thermogenic and fat-oxidation-enhancing supplementation may act as a safe and effective metabolic modulator, particularly when combined with exercise, positioning it as an innovative strategy for adults presenting mild metabolic risk.\n\nThe present study would integrate: (1) a multicomponent functional exercise program designed to improve strength, balance, and aerobic capacity in older adults; (2) a thermogenic and fat-oxidation-enhancing nutritional supplement as a safe metabolic activation strategy; (3) a standardized dietary control protocol to isolate the specific effects of the supplementation; (4) dual-energy X-ray absorptiometry (DXA) for precise body composition assessment; (5) hormonal and lipid biomarkers to evaluate underlying physiological mechanisms; and (6) validated questionnaires addressing quality of life, sleep, and appetite to capture the holistic dimension of this stage of adulthood.\n\nThis multidimensional approach would provide an innovative intervention for a growing yet underexplored population: non-obese but metabolically challenged adults at increasing cardiometabolic risk.\n\nReferences:\n\n* Jiménez-Martínez P, Sánchez-Valdepeñas J, Cornejo-Daza PJ, Cano-Castillo C, Asín-Izquierdo I, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on neuromuscular activity and mechanical performance in trained male subjects: a randomized, triple-blinded, crossover, placebo-controlled trial. Front Physiol. 2023a Aug 2; 14: 1215644.\n* Jiménez-Martínez P, Cornejo-Daza PJ, Sánchez-Valdepeñas J, Asín-Izquierdo I, Cano-Castillo C, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on resistance training performance, muscle damage, protein breakdown, metabolic response, ratings of perceived exertion, and recovery: a randomized, triple-blinded, placebo-controlled, crossover trial. J Int Soc Sports Nutr. 2023b Dec; 20 (1): 2204083.\n* Stefan N. Metabolically healthy and unhealthy normal weight and obesity. Endocrinol Metab (Seoul). 2020 Sep;35(3):487-493.\n* Xiong Q, Zang Y, Li J, An Y, and Yu S. Comparison of cardiovascular disease risk association with metabolic unhealthy obesity identified by body fat percentage and body mass index: Results from the 1999-2020 National Health and Nutrition Examination Survey. PLoS One. 2024 Aug 14; 19 (8): e0305592.\n* Wu Y, Li D, and Vermund SH. Advantages and limitations of the body mass index (BMI) to assess adult obesity. Int J Environ Res Public Health. 2024 Jun 10; 21 (6): 757.",[27,28,29,30],"Aging","Adults With Overweight and Obesity","Supplementation","Exercise",[32,33,34,35,36,37,38,39],"Older adults","Adults with metabolic disorders","Nutritional supplement","Multicomponent exercise","Healthy aging","Quality of life","Non-pharmacological intervention","Randomized controlled trial","RECRUITING","2026-04-27",{"date":43,"type":44},"2026-05-04","ACTUAL",{"date":46,"type":44},"2026-03-25",{"date":48,"type":21},"2026-07-30",{"name":50,"class":51},"University of Valencia","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":4},"100621489","administration-of-fiber-as-a-dietary-supplement-to-improve-the-management-of-alcohol-withdrawal-100621489","NCT07371286","Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal","Administration of Fiber as a Dietary Supplement to Improve the Management of Alcohol Withdrawal - Randomized Controlled Open-label Study - FIB-ALC","FIB-ALC","Inclusion Criteria:\n\n* Women or men,\n* aged \\>18 and ≤ 65,\n* French-speaking,\n* active alcohol users (as defined by the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, DSM-5)\n* who agree to be hospitalized for alcohol withdrawal for a period of 7 days\n* Affiliated with or eligible for social security.\n* Negative pregnancy test (for patients of childbearing age)\n\nExclusion Criteria:\n\n* any other addictive disorder (except tobacco),\n* inflammatory bowel disease or any other chronic inflammatory disease,\n* current cancer,\n* metabolic diseases such as obesity (BMI ≥ 30 kg\u002Fm²) kg\u002Fm2) or a history of bariatric surgery,\n* severe cognitive impairment (MMSE \\\u003C 24),\n* psychiatric comorbidities including suicide risk,\n* cirrhosis or significant fibrosis (≥F2) defined by a Fibroscan value \\>7.6 kPa,\n* pregnancy or breastfeeding,\n* taking antibiotics, probiotics, or prebiotics in the 2 months prior to inclusion,\n* taking non-steroidal anti-inflammatory drugs or glucocorticoids in the month prior to inclusion.\n* taking baclofen, disulfiram, naltrexone, or acamprosate.\n* Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable\n* Patients under AME\n* Patients under guardianship, trusteeship, or any other legal protection measure","19 Years",{"count":63,"type":21},138,[24],"The goal of this clinical trial is to demonstrate that a fiber-enriched diet (with a high proportion of inulin and pectin) combined with standard care can reduce intestinal permeability in patients with alcohol use disorder (AUD) aged between 19 and 65.\n\nThe hypothesis of our study is that a diet rich in different dietary fibers (mainly inulin and pectin), by modifying the gut microbiota and its metabolites, will induce a decrease in intestinal permeability, restore the composition of the gut microbiota and its metabolites, and further improve abstinence, levels of craving and anxiety, inflammation, steatosis, and hepatic fibrosis in patients with alcohol use disorder.\n\nThe study consists of two parallel groups (a group eating fiber-rich snacks every day for 28 days (in addition to their usual care) versus a group not eating any snacks).\n\nParticipants will be required to provide stool, blood, and saliva samples, and complete questionnaires.",[67,29,68],"Alcohol Use Disorder","Intestinal Permeability",[70,71,72,73,74],"Alcohol","Dietary fibers","Food supplementation","Intestinal permeability","Misuse","NOT_YET_RECRUITING","2026-01-19",{"date":78,"type":44},"2026-01-27",{"date":80,"type":21},"2026-02",{"date":80,"type":21},{"name":83,"class":51},"Assistance Publique - Hôpitaux de Paris",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":52},"100609321","effects-of-chronic-creatine-and-beta-hydroxy-beta-methylbutyrate-supplementation-on-oxidative-stress-inflammation-muscle-strength-and-body-composition-in-individuals-with-down-syndrome-100609321","NCT07213063","Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome","Inclusion Criteria:\n\n* Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21).\n* Physical capacity: Ability to perform basic physical tests (e.g., standing up from a chair or walking without assistance).\n* Informed consent: Informed consent will be obtained from both the participant and their legal representative, in compliance with current legislation for individuals requiring support measures.\n\nExclusion Criteria:\n\n* Chronic kidney disease: Diagnosis of chronic kidney disease.\n* Severe motor limitations: Inability to perform the required physical tests (e.g., paralysis or mobility impairments preventing the execution of muscle strength assessments).\n* Participation in other studies: Participation in another nutritional or supplementation intervention study within the last 6 months.\n* Allergies or intolerances: Known allergy to creatine or to components of the placebo (inulin).","18 Years",{"count":92,"type":21},50,[24],"Purpose:\n\nThis study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study.\n\nWho can participate:\n\nPeople with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian.\n\nWhat participants will do:\n\nTake creatine (3 g\u002Fday) and HMB (3 g\u002Fday) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers.\n\nTiming:\n\nAll tests and blood samples are taken before and after each 8-week period.\n\nImportance:\n\nResults will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.",[96,29],"Down Syndrome (DS)",[98,99,100],"creatine","down syndrome","bone mineral health","2026-01-12",{"date":103,"type":44},"2026-01-14",{"date":105,"type":44},"2025-09-15",{"date":107,"type":21},"2026-05-30",{"name":109,"class":51},"Universidad de Burgos",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":17,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":52},"100612376","phase-2-effect-of-a-short-term-multi-strain-probiotic-supplementation-in-endurance-athletes-100612376","NCT07252778","Effect of a Short-term Multi-strain Probiotic Supplementation in Endurance Athletes","Effect of a Short-term Multi-strain Probiotic Supplementation on the Exercise- Associated Gastrointestinal Disturbances in Trained Female Athletes Under Controlled Conditions During Professional Training Cycle","Inclusion Criteria:\n\n* belonging to the national rowing team;\n* training experience ≥5 years;\n* a currently issued medical certificate confirming\n* good health and capacity to practice sports;\n* good health without chronic health disorders;\n* written informed consent to participate.\n\nExclusion Criteria:\n\n* injury, any health contraindication or failure to perform exercise procedures;\n* gastrointestinal infections, diseases, disorders;\n* past history of gastrointestinal surgery, and\n* other self-reported gastrointestinal issues;\n* reporting symptoms of infection or taking any medication (e.g. antibiotics) for 4 weeks before the study protocol;\n* current supplementation of prebiotics,\n* probiotics, synbiotics (last 4 weeks);\n* current intake of pharmaceutical agents (e.g., nonsteroidal anti-inflammatory drugs, laxatives, antidiarrhea agents, antacids, and\u002For antiemetics) (last 4 weeks);\n* failure to follow the study protocol;\n* declared general feeling of being unwell;\n* pregnancy or current pregnancy planning.",true,"FEMALE","16 Years",{"count":121,"type":21},30,[123,124],"PHASE2","PHASE3","The aim of this project is to evaluate and identify the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on the exercise-associated gastrointestinal (GI) symptoms and perturbations in high level female athletes of the Polish national team during strictly controlled conditions of a training camp, based on recommendations for best practices for probiotic (PRO) research in athletes and assessment of EX-associated GI perturbations.",[127,128,129,130,29],"Sports Nutrition","Biochemical Markers","Exercise Performance","Aerobic Capacity",[132,133,134,135,136],"Probiotics","Gastro-intestinal markers","Microbiota","Rowing","Females","2025-11-18",{"date":139,"type":44},"2025-11-28",{"date":141,"type":21},"2025-11-20",{"date":143,"type":21},"2027-06-30",{"name":145,"class":51},"Krzysztof Durkalec-Michalski",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":52},"100600087","phase-3-effects-of--alanine-and-sodium-bicarbonate-supplementation-on-physical-capacity-and-biochemical-markers-concentrations-100600087","NCT07092930","Effects of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Biochemical Markers Concentrations","Evaluation of the Synergistic Effect of β-alanine and Sodium Bicarbonate Supplementation on Physical Capacity and Blood Biochemical Markers Concentrations in Trained Female Basketball Players","Inclusion Criteria:\n\n* written consent to participate,\n* general good health condition,\n* a current medical clearance to practice sports,\n* training experience: at least 4 years,\n* minimum of 4 workout sessions (in the discipline covered by the study) a week.\n\nExclusion Criteria:\n\n* current injury,\n* any health-related contraindication,\n* declared general feeling of being unwell,\n* taking supplements, especially ergogenic supplements that modulate extra- and intracellular capacity 3 months prior to research (except taking protein and\u002For carbohydrate powders, isotonic drinks),\n* unwilling to follow the study protocol.","40 Years",{"count":155,"type":21},100,[124],"This randomized, double-blind, placebo-controlled, parallel-group study aims to evaluate the potential synergistic effect of beta-alanine (BA) and sodium bicarbonate (SB) supplementation, compared to their separate administration or placebo (PL), on physical performance and selected blood biochemical markers in highly trained female basketball players.",[29,159,160],"Sports","Female Athletes",[162,163,164,165,166,167,168,169],"Beta-alanine","Sodium bicarbonate","Ergogenic aids","Sports nutrition","Team sports","Physical capacity","Body composition","Blood and urine biochemical markers","2025-07-28",{"date":172,"type":44},"2025-07-30",{"date":174,"type":44},"2023-10-01",{"date":176,"type":21},"2025-12",{"name":178,"class":51},"Poznan University of Physical Education",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":52},"100578374","evaluation-of-the-effects-of-two-dietary-supplement-formulations-on-the-lipid-profile-in-mild-hypercholesterolemia-100578374","NCT06810466","Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia","A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia","Inclusion Criteria:\n\n* Prevention of cardiovascular disease\n* Low cardiovascular risk (\\\u003C 5%)\n* Sub-optimal serum levels of LDL-C (130-136 mg\u002Fdl; 3.37-4.14 mmol\u002Fl) and\u002For non-HDL-C (160-190 mg\u002Fdl; 4.14-4.92 mmol\u002Fl) at T-2\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \\>\u002F= 5)\n* diabetes mellitus\n* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism\n* Hypertension treatment not stabilized for at least 3 months\n* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease\n* Any medical-surgical treatment that may limit adherence to the study protocol\n* Pregnant and\u002For breastfeeding women","69 Years",{"count":188,"type":21},99,[24],"A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.\n\nThe study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:\n\nGroup A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo\n\nThe following visits are scheduled during the study:\n\nT-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.",[192,29],"Hypercholesterolemia and Hyperlipidemia",[194,195,196,197],"mild hypercholesterolemia","supplement","lipid profile","dietary supplement","2025-01-30",{"date":200,"type":44},"2025-02-05",{"date":202,"type":44},"2024-12-17",{"date":204,"type":21},"2026-01",{"name":206,"class":207},"IBSA Farmaceutici Italia Srl","INDUSTRY"]