Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Muscle Function; Obesity & Overweight; Muscle Mass and Strength

Treatments: Dietary Supplement: Maltodextrin Placebo Capsules; Dietary Supplement: Whey Protein Supplementation; Dietary Supplement: Mixed Spice Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT07806838

25-0763

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups, including a placebo group

Arm 1 - Standard of Care

No Intervention group

Description:

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/calorie 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.

Protein Supplementation + Placebo

Placebo Comparator group

Description:

Participants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg 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/calorie and physical activity guidance.

Treatment:

Dietary Supplement: Maltodextrin Placebo Capsules

Dietary Supplement: Whey Protein Supplementation

Protein Supplementation + Mixed Spices

Experimental group

Description:

Participants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg 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/calorie and physical activity guidance.

Treatment:

Dietary Supplement: Mixed Spice Capsules

Dietary Supplement: Whey Protein Supplementation