[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adults-with-overweight-and-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adults-with-overweight-and-obesity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":52},"100585044","personalized-metabolic-responses-to-rapid-slow-and-resistant-starch-100585044","NCT06897241","Personalized Metabolic Responses to Rapid, Slow and Resistant Starch","Personalized Metabolic Responses to Rapid, Slow and Resistant Starch (PerStarch)","PerStarch","Inclusion Criteria:\n\n* Men and post-menopausal women\n* Age 30-75 years\n* BMI 27-40 kg\u002Fm2\n* Waist circumference \\> 102\u002F88 cm for men\u002Fwomen\n* Weight stable during previous 3 months (± 3 kg)\n* Willingness to consume the intervention diets\n* Ability to deal with the monitoring devices\n* Medications stable for the previous 14 days\n* Signed informed consent\n\nExclusion Criteria:\n\n* Cardiovascular events (myocardial infarction or stroke) during the previous 6 months\n* Diagnosis of diabetes (any type) or use of any drug who can interfere with glucose homeostasis (i.e., metformin, incretin analogues, SGLT-2 inhibitors)\n* History of stomach or gastrointestinal conditions (inflammatory bowel disease, Crohn's disease, malabsorption, etc.)\n* Colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery\n* Renal or liver failure (creatinine \\\u003C1.7 mg\u002Fdl and alanine aminotransferase\u002Faspartate aminotransferase \\\u003C 2 times than normal values, respectively)\n* Anemia (hemoglobin below the age and sex specific normal reference ranges at screening)\n* Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion\n* Having been treated with antibiotics within the past 3 months or planning to undergo treatment during the study period.\n* Habitual use of probiotic\u002Fprebiotic supplements or foods enriched in probiotics\n* Celiac disease\n* Vegan\u002Fvegetarian diet (or a diet incompatible with protocol diets)\n* Intense physical activity regimen (\\> 7 h\u002Fweek of moderate intensity or \\> 3 h\u002Fweek of high intensity)\n* History of drug or alcohol abuse\n* Not able to understand written and spoken Swedish\n* Any other reason for lack of suitability for participation in the trial, as judged by the principal investor or co-principal investigator","30 Years","75 Years",{"count":64,"type":21},96,[24],"The study aims to investigate how individuals with varying gut microbiota composition and AMY1 gene copy number respond to three different types of starch. A 12-week trial will therefore be conducted, where all participants will go through three different 17-day interventions in a randomized order. Each intervention will contain a different type of starch:\n\nA) Resistant starch B) Slow digestible starch C) Rapid digestible starch\n\nEach intervention will contain a preparation day, a meal challenge test day at clinic, a 14-day dietary intervention at home followed by a follow up visit at clinic. The interventions will be separated with a 14-day wash-out period, where participants are consuming their normal food.\n\nBlood, saliva and fecal samples will be collected during the trial, together with data from continuous glucose monitoring and body measurements. Questionnaires on dietary intake and lifestyle, food preferences, self-reported appetite, health-related quality of life, sleep quality and daytime sleepiness will also be filled out by the participants.",[28],[69,70,71,72,73,74,75],"Glucose metabolism","Prevotella","AMY1 copy number","Continuous glucose monitoring","Meal tolerance test","Fecal redox potential","Home sampling","2025-05-14",{"date":78,"type":44},"2025-05-16",{"date":80,"type":44},"2025-04-08",{"date":82,"type":21},"2026-05-01",{"name":84,"class":51},"Chalmers University of Technology"]