[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655105":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":53,"studyPopulation":53,"armGroups":84,"interventions":102,"overallOfficials":116,"centralContacts":120,"locations":126,"responsibleParty":144,"collaborators":53,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":53,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":154,"minAge":155,"maxAge":53,"enrollmentInfo":156,"targetDuration":53,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":53,"overallStatus":129,"whyStopped":53,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":53},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Muscle Mass Measured by DEXA","Muscle mass will be assessed using dual-energy X-ray absorptiometry (DEXA). Change in muscle mass from baseline to 6 months will be compared among the three study groups.","Baseline, 3 months, and 6 months",{"measure":14,"description":15,"timeFrame":16},"Change in Muscle Mass Measured by D3-Creatine Enrichment","Muscle mass will be assessed using the D3-creatine (D3Cr) dilution method. Change in muscle mass from baseline to 6 months will be compared among the three study groups. Urinary D3-creatine enrichment will be measured by liquid chromatography with tandem mass spectrometry and used to estimate total body skeletal muscle mass.","Baseline and 6 months",[18,22,25,28,31,34,38,41,44,47,51,54,57,60,63,66,70,73],{"measure":19,"description":20,"timeFrame":21},"Change in 400-Meter Walk Test Performance","Muscle function will be assessed using the 400-meter walk test.","Baseline, 1 month, 3 months, and 6 months",{"measure":23,"description":24,"timeFrame":21},"Change in Stair Climbing Test Performance","Muscle function will be assessed using a stair climbing test.",{"measure":26,"description":27,"timeFrame":21},"Change in Grip Strength","Grip strength will be measured using a handheld dynamometer and recorded in kilograms. The best of three trials for each hand will be used in the analysis.",{"measure":29,"description":30,"timeFrame":12},"Change in Mitochondrial Function","Mitochondrial function will be assessed in peripheral blood mononuclear cells (PBMCs), including autophagy and mitochondrial assays.",{"measure":32,"description":33,"timeFrame":12},"Change in Fasting Glucose","Fasting glucose will be measured to assess glucose homeostasis.",{"measure":35,"description":36,"timeFrame":37},"Change in Fasting Insulin","Fasting insulin will be measured to assess insulin sensitivity.","Time Frame: Baseline to 6 months",{"measure":39,"description":40,"timeFrame":12},"Change in C-Peptide","Description: Fasting C-peptide will be measured as a marker of pancreatic beta-cell function.",{"measure":42,"description":43,"timeFrame":12},"Change in Glucagon","Description: Fasting glucagon will be measured as a metabolic marker.",{"measure":45,"description":46,"timeFrame":12},"Change in Glucose-Dependent Insulinotropic Polypeptide (GIP)","Fasting GIP will be measured to evaluate metabolic pathways related to glucose regulation.",{"measure":48,"description":49,"timeFrame":50},"Change in High-Sensitivity C-Reactive Protein (hs-CRP)","Description: High-sensitivity C-reactive protein will be measured as a marker of systemic inflammation.","Time Frame: Baseline, 3 months, and 6 months",{"measure":52,"description":53,"timeFrame":21},"Change in Body Weight",null,{"measure":55,"description":56,"timeFrame":21},"Change in Body Composition by Bioelectrical Impedance Analysis","Body composition will be assessed using an InBody bioelectrical",{"measure":58,"description":59,"timeFrame":21},"Change in Fatigue Assessed by PROMIS Fatigue Short Form 8a","Fatigue will be assessed using the PROMIS Fatigue Short Form 8-item questionnaire.",{"measure":61,"description":62,"timeFrame":21},"Change in Quality of Life Assessed by SF-36","Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).",{"measure":64,"description":65,"timeFrame":21},"Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.",{"measure":67,"description":68,"timeFrame":69},"Change in Dietary Energy and Macronutrient Intake","Dietary energy and macronutrient intake will be assessed using 24-hour dietary recalls.","Baseline, 1 month, 3 months, 4.5 months, and 6 months",{"measure":71,"description":72,"timeFrame":69},"Change in Physical Activity","Physical activity will be monitored using step counts from participants' personal devices and self-reported physical activity recorded using MyNetDiary.",{"measure":74,"description":75,"timeFrame":16},"Change in Gut Microbiome Composition","Gut microbiome composition will be assessed using fecal samples",{"allocation":77,"interventionModel":78,"interventionModelDescription":53,"primaryPurpose":79,"observationalModel":53,"timePerspective":53,"maskingInfo":80},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":81,"maskingDescription":53,"whoMasked":82},"SINGLE",[83],"OUTCOMES_ASSESSOR",[85,89,96],{"label":86,"type":87,"description":88,"interventionNames":53},"Arm 1 - Standard of Care","NO_INTERVENTION","Participants will continue their prescribed GLP-1 medication and routine clinical management under the direction of their treating healthcare provider. The study will not determine GLP-1 medication selection, dosing, dose adjustments, or clinical management. Participants will receive standardized dietary\u002Fcalorie and physical activity guidance and will complete the same study assessments and follow-up visits as participants in the intervention groups. They will not receive the study protein supplement, spice capsules, or placebo capsules.",{"label":90,"type":91,"description":92,"interventionNames":93},"Protein Supplementation + Placebo","PLACEBO_COMPARATOR","Participants will receive protein supplementation with a goal of total protein intake of 1.2 g\u002Fkg lean body mass per day, based on baseline lean body mass measured by DEXA, plus placebo capsules containing 4 g of maltodextrin daily for 6 months. Participants will also receive standardized dietary\u002Fcalorie and physical activity guidance.",[94,95],"Dietary Supplement: Whey Protein Supplementation","Dietary Supplement: Maltodextrin Placebo Capsules",{"label":97,"type":98,"description":99,"interventionNames":100},"Protein Supplementation + Mixed Spices","EXPERIMENTAL","Participants will receive protein supplementation with a goal of total protein intake of 1.2 g\u002Fkg lean body mass per day, based on baseline lean body mass measured by DEXA, plus 4 g of mixed spice capsules daily for 6 months. The daily spice mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme. Participants will also receive standardized dietary\u002Fcalorie and physical activity guidance.",[94,101],"Dietary Supplement: Mixed Spice Capsules",[103,108,112],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":53},"DIETARY_SUPPLEMENT","Whey Protein Supplementation","Participants will receive Nutrasumma 100% Whey Protein Isolate (unflavored), providing 20 g whey protein isolate per serving. The 20 g of protein from the shake will count toward the total daily protein goal of 1.2 g\u002Fkg lean body mass\u002Fday. The remaining protein target will be met through the participant's usual diet.",[97,90],{"type":104,"name":109,"description":110,"armGroupLabels":111,"otherNames":53},"Maltodextrin Placebo Capsules","Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.",[90],{"type":104,"name":113,"description":114,"armGroupLabels":115,"otherNames":53},"Mixed Spice Capsules","Participants will consume 4 g of mixed spice capsules daily for 6 months. The daily mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme.",[97],[117],{"name":118,"affiliation":5,"role":119},"Zhaoping Li","PRINCIPAL_INVESTIGATOR",[121],{"name":122,"role":123,"phone":124,"phoneExt":53,"email":125},"Hila Zelicha, PhD, MS, RD","CONTACT","310-206-8292","uclanutrition@gmail.com",[127],{"facility":128,"status":129,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"UCLA Center for Human Nutrition","RECRUITING","Los Angeles","California","90024","United States","US",{"type":136,"coordinates":137},"Point",[138,139],-118.24368,34.05223,{"lat":139,"lon":138},[142],{"name":143,"role":123,"phone":124,"phoneExt":53,"email":125},"Hila Zelicha",{"type":119,"investigatorFullName":118,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles","100655105","effects-of-dietary-supplements-on-muscle-mass-and-function-while-using-glp-1-medication-100655105",false,"NCT07806838","Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication","The Effect of Daily Mixed Spice Consumption and Protein Supplementation on Muscle Mass and Function in Adults Using GLP-1 Agonists for Weight Management: A Pilot Study","Inclusion Criteria:\n\n1. Male or female ≥18 years of age at screening visit.\n2. BMI \\>27 kg\u002Fm² with weight-related conditions OR BMI \\>30 kg\u002Fm².\n3. Taking any FDA-approved GLP-1 medication, daily oral or weekly injectable, started up to three months ago, and experiencing at least 1 lb of weight loss per week.\n4. Screening laboratory tests without significant abnormalities that might interfere with the study.\n\nExclusion Criteria:\n\n1. Consume spices regularly \\>5 g\u002Fday.\n2. Allergy or sensitivity to spices, or history of allergy or anaphylaxis of any kind.\n3. Diagnosed with Type 2 diabetes.\n4. Vegans\u002Fvegetarians.\n5. Consuming protein, amino acid, or creatine supplements; occasional or infrequent use (1 serving per week or less) is allowed.\n6. Milk protein allergy.\n7. Severe lactose intolerance.\n8. Current diagnosis of alcoholism or substance addiction.\n9. Uncontrolled hypertension (systolic BP \\>170 or diastolic BP \\>100).\n10. Eating a high-fiber\u002Fpolyphenol diet or taking medication or dietary supplements that interfere with the absorption of polyphenols.\n11. Frequently using prebiotics, probiotics, yogurt, and\u002For fiber supplements.\n12. Pregnant, breastfeeding, or unwilling to practice birth control during study participation.\n13. Presence of a condition or abnormality that, in the opinion of the investigator, would compromise participant safety or data quality.\n14. Renal impairment measured as eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m² (\\\u003C60 mL\u002Fmin\u002F1.73 m² in subjects treated with SGLT2i), according to the CKD-EPI creatinine equation as defined by KDIGO 2012.\n15. Any unstable medical conditions or terminal diagnosis.\n16. Unstable thyroid disease-not taking medication or medication dosage changed one or more times over the last 6 months. Stable thyroid disease on an unchanged prescription medication dose for ≥6 months is acceptable.\n17. Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, or DPP4 as single-agent therapy or combination oral agents.\n18. Taking GLP-1 medications for more than 3 months.\n19. Have a medical implant or other metal implant, including a pacemaker.\n20. Unwilling to stay on a GLP-1 medication for 6 months or for the duration of study participation.",true,"ALL","18 Years",{"count":157,"type":158},75,"ESTIMATED","INTERVENTIONAL",[161],"NA","This pilot study will examine whether daily protein supplementation with or without a mixture of culinary spices can help preserve muscle mass and function in adults who are using GLP-1 medications for weight management.\n\nThe study will include 75 adults who recently started a GLP-1 medication and are experiencing weight loss. Participants will be randomly assigned to one of three groups: standard of care, protein supplementation plus placebo capsules, or protein supplementation plus mixed spice capsules. The study will last 6 months.\n\nResearchers will compare changes in muscle mass and muscle function among the groups. Muscle mass will be measured using DEXA and D3-creatine enrichment. Muscle function will be assessed using walking, stair-climbing, and grip-strength tests. The study will also evaluate metabolic and inflammatory markers, body composition, dietary intake, physical activity, fatigue, sleep quality, quality of life, and other measures related to muscle health.",[164,165,166],"Obesity & Overweight","Muscle Mass and Strength","Muscle Function","2026-09-01",{"date":169,"type":170},"2026-09-08","ACTUAL",{"date":172,"type":158},"2026-09-10",{"date":174,"type":158},"2028-09-01",{"name":5,"class":6},1]