Recruiting

Protein Supplementation

Sponsor:

UCLA

Code:

NCT07806838

Conditions

Obesity & Overweight

Muscle Mass and Strength

Muscle Function

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Whey Protein Supplementation

Maltodextrin Placebo Capsules

Mixed Spice Capsules

Study Details

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.

Conditions

Obesity & Overweight

Muscle Mass and Strength

Muscle Function

Study ID

NCT07806838

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Arm 1 - Standard of Care

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.

placebo comparator: Protein Supplementation + Placebo

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.

experimental: Protein Supplementation + Mixed Spices

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.

Interventions

Whey 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.

Maltodextrin Placebo Capsules

Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.

Mixed 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.

Primary outcome measure

  • Change in Muscle Mass Measured by DEXA [ Time Frame: Baseline, 3 months, and 6 months ]
  • Change in Muscle Mass Measured by D3-Creatine Enrichment [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Hila Zelicha, PhD, MS, RD

310-206-8292uclanutrition@gmail.com

Locations

UCLA Center for Human Nutrition

Recruiting

Los Angeles, California, United States, 90024

Contacts

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-09-08.