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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether daily protein supplements, with or without cooking spices, help protect muscle size and strength during weight loss. It is for adults who recently started GLP-1 medicine for weight control. The study lasts 6 months and compares usual care, protein with dummy pills, and protein with spice pills.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are at least 18 years old.
- Your BMI, a weight measure based on height, is above 27 with a weight-related health problem, or above 30.
- You started an FDA-approved GLP-1 medicine within the past 3 months, taken as a daily pill or weekly shot.
- You are losing at least 1 pound per week.
- Your screening lab tests show no major problems that could affect the study.
Who can't join
- You eat more than 5 grams of spices daily; are vegan or vegetarian; eat a diet high in fiber or polyphenols (plant compounds); or often use prebiotics, probiotics, yogurt, or fiber supplements.
- You have spice sensitivity, any past allergy or severe allergic reaction, a milk protein allergy, or severe trouble digesting milk sugar.
- You use protein, amino acid, or creatine supplements more than once a week, or take medicines or supplements that affect how your body absorbs polyphenols.
- You have type 2 diabetes, a current alcohol or drug addiction, or blood pressure with a top number above 170 or bottom number above 100.
- You have low kidney function: an eGFR blood test result below 45, or below 60 if you take an SGLT2 inhibitor medicine. You have an unstable illness, a terminal illness, or another health problem that could make the study unsafe or affect its results.
- You have unstable thyroid disease, are not taking medicine for it, or changed its medicine dose in the past 6 months. You use insulin or diabetes pills called metformin, SU, SGLT2 inhibitors, glitazones, or DPP4 inhibitors.
- You are pregnant, breastfeeding, or unwilling to use birth control during the study. You have a medical or metal implant, including a pacemaker.
- You have used GLP-1 medicine for more than 3 months, or are unwilling to keep taking it for the full 6-month study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
CA
- UCLA Center for Human Nutrition · Los Angeles, CA 90024Hila Zelicha · Study contact · 310-206-8292 · uclanutrition@gmail.comMore trials in Los Angeles