Protein supplements with or without spices to protect muscle for people on GLP-1 weight loss meds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot study will enroll 75 adults who recently started a GLP-1 medication for weight management. Participants will be assigned to one of three groups: standard of care, protein supplementation with placebo capsules, or protein supplementation with mixed spice capsules, over six months. Muscle mass will be assessed with DEXA and D3-creatine enrichment, while muscle function will be evaluated through walking tests, stair climbing, and grip strength, along with metabolic and inflammatory markers and other health measures. Additional outcomes include body composition, dietary intake, physical activity, fatigue, sleep quality, and quality of life related to muscle health.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCLA Center for Human Nutrition
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Zhaoping Li — University of California, Los Angeles
• Study coordinator: Hila Zelicha, PhD, MS, RD
• Email: uclanutrition@gmail.com
• Phone: 310-206-8292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.