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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.