Obesity & Overweight, Muscle Mass and Strength, Muscle Function
Conditions
Brief summary
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. The 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. Researchers 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.
Interventions
DIETARY_SUPPLEMENTWhey 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/kg lean body mass/day. The remaining protein target will be met through the participant's usual diet.
DIETARY_SUPPLEMENTMaltodextrin Placebo Capsules
Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.
DIETARY_SUPPLEMENTMixed 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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female ≥18 years of age at screening visit. 2. BMI \>27 kg/m² with weight-related conditions OR BMI \>30 kg/m². 3. 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. 4. Screening laboratory tests without significant abnormalities that might interfere with the study.
Exclusion criteria
1. Consume spices regularly \>5 g/day. 2. Allergy or sensitivity to spices, or history of allergy or anaphylaxis of any kind. 3. Diagnosed with Type 2 diabetes. 4. Vegans/vegetarians. 5. Consuming protein, amino acid, or creatine supplements; occasional or infrequent use (1 serving per week or less) is allowed. 6. Milk protein allergy. 7. Severe lactose intolerance. 8. Current diagnosis of alcoholism or substance addiction. 9. Uncontrolled hypertension (systolic BP \>170 or diastolic BP \>100). 10. Eating a high-fiber/polyphenol diet or taking medication or dietary supplements that interfere with the absorption of polyphenols. 11. Frequently using prebiotics, probiotics, yogurt, and/or fiber supplements. 12. Pregnant, breastfeeding, or unwilling to practice birth control during study participation. 13. Presence of a condition or abnormality that, in the opinion of the investigator, would compromise participant safety or data quality. 14. Renal impairment measured as eGFR \<45 mL/min/1.73 m² (\<60 mL/min/1.73 m² in subjects treated with SGLT2i), according to the CKD-EPI creatinine equation as defined by KDIGO 2012. 15. Any unstable medical conditions or terminal diagnosis. 16. 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. 17. Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, or DPP4 as single-agent therapy or combination oral agents. 18. Taking GLP-1 medications for more than 3 months. 19. Have a medical implant or other metal implant, including a pacemaker. 20. Unwilling to stay on a GLP-1 medication for 6 months or for the duration of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Mass Measured by DEXA | Baseline, 3 months, and 6 months | 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. |
| Change in Muscle Mass Measured by D3-Creatine Enrichment | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Glucose | Baseline, 3 months, and 6 months | Fasting glucose will be measured to assess glucose homeostasis. |
| Change in Fasting Insulin | Time Frame: Baseline to 6 months | Fasting insulin will be measured to assess insulin sensitivity. |
| Change in C-Peptide | Baseline, 3 months, and 6 months | Description: Fasting C-peptide will be measured as a marker of pancreatic beta-cell function. |
| Change in Glucagon | Baseline, 3 months, and 6 months | Description: Fasting glucagon will be measured as a metabolic marker. |
| Change in Glucose-Dependent Insulinotropic Polypeptide (GIP) | Baseline, 3 months, and 6 months | Fasting GIP will be measured to evaluate metabolic pathways related to glucose regulation. |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Time Frame: Baseline, 3 months, and 6 months | Description: High-sensitivity C-reactive protein will be measured as a marker of systemic inflammation. |
| Change in Body Weight | Baseline, 1 month, 3 months, and 6 months | — |
| Change in Body Composition by Bioelectrical Impedance Analysis | Baseline, 1 month, 3 months, and 6 months | Body composition will be assessed using an InBody bioelectrical |
| Change in Fatigue Assessed by PROMIS Fatigue Short Form 8a | Baseline, 1 month, 3 months, and 6 months | Fatigue will be assessed using the PROMIS Fatigue Short Form 8-item questionnaire. |
| Change in Quality of Life Assessed by SF-36 | Baseline, 1 month, 3 months, and 6 months | Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). |
| Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI) | Baseline, 1 month, 3 months, and 6 months | 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. |
| Change in Dietary Energy and Macronutrient Intake | Baseline, 1 month, 3 months, 4.5 months, and 6 months | Dietary energy and macronutrient intake will be assessed using 24-hour dietary recalls. |
| Change in Physical Activity | Baseline, 1 month, 3 months, 4.5 months, and 6 months | Physical activity will be monitored using step counts from participants' personal devices and self-reported physical activity recorded using MyNetDiary. |
| Change in Gut Microbiome Composition | Baseline and 6 months | Gut microbiome composition will be assessed using fecal samples |
| Change in 400-Meter Walk Test Performance | Baseline, 1 month, 3 months, and 6 months | Muscle function will be assessed using the 400-meter walk test. |
| Change in Grip Strength | Baseline, 1 month, 3 months, and 6 months | 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. |
| Change in Stair Climbing Test Performance | Baseline, 1 month, 3 months, and 6 months | Muscle function will be assessed using a stair climbing test. |
| Change in Mitochondrial Function | Baseline, 3 months, and 6 months | Mitochondrial function will be assessed in peripheral blood mononuclear cells (PBMCs), including autophagy and mitochondrial assays. |
Countries
United States
Contacts
CONTACTHila Zelicha, PhD, MS, RD
PRINCIPAL_INVESTIGATORZhaoping Li
University of California, Los Angeles
Outcome results
None listed