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

NCT07806838 | Recruiting

• 1 other identifier: 25-0763
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Muscle Mass Measured by DEXA

  Muscle mass will be assessed using dual-energy X-ray absorptiometry (DEXA). Change in muscle mass from baseline to 6 months will be compared among the three study groups.

  Baseline, 3 months, and 6 months

• Change in Muscle Mass Measured by D3-Creatine Enrichment

  Muscle mass will be assessed using the D3-creatine (D3Cr) dilution method. Change in muscle mass from baseline to 6 months will be compared among the three study groups. Urinary D3-creatine enrichment will be measured by liquid chromatography with tandem mass spectrometry and used to estimate total body skeletal muscle mass.

  Baseline and 6 months

Secondary Outcomes (18)

• Change in 400-Meter Walk Test Performance

  Baseline, 1 month, 3 months, and 6 months

• Change in Stair Climbing Test Performance

  Baseline, 1 month, 3 months, and 6 months

• Change in Grip Strength

  Baseline, 1 month, 3 months, and 6 months

• Change in Mitochondrial Function

  Baseline, 3 months, and 6 months

• Change in Fasting Glucose

  Baseline, 3 months, and 6 months

Study Arms (3)

Arm 1 - Standard of Care

NO INTERVENTION

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

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.

Dietary Supplement: Whey Protein Supplementation; Dietary Supplement: Maltodextrin Placebo Capsules

Protein Supplementation + Mixed Spices

EXPERIMENTAL

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.

Dietary Supplement: Whey Protein Supplementation; Dietary Supplement: Mixed Spice Capsules

Interventions

Whey Protein Supplementation DIETARY_SUPPLEMENT

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.

Protein Supplementation + Mixed Spices; Protein Supplementation + Placebo

Maltodextrin Placebo Capsules DIETARY_SUPPLEMENT

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

Protein Supplementation + Placebo

Mixed Spice Capsules DIETARY_SUPPLEMENT

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.

Protein Supplementation + Mixed Spices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age at screening visit.
• BMI \>27 kg/m² with weight-related conditions OR BMI \>30 kg/m².
• 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.
• Screening laboratory tests without significant abnormalities that might interfere with the study.

You may not qualify if:

• Consume spices regularly \>5 g/day.
• Allergy or sensitivity to spices, or history of allergy or anaphylaxis of any kind.
• Diagnosed with Type 2 diabetes.
• Vegans/vegetarians.
• Consuming protein, amino acid, or creatine supplements; occasional or infrequent use (1 serving per week or less) is allowed.
• Milk protein allergy.
• Severe lactose intolerance.
• Current diagnosis of alcoholism or substance addiction.
• Uncontrolled hypertension (systolic BP \>170 or diastolic BP \>100).
• Eating a high-fiber/polyphenol diet or taking medication or dietary supplements that interfere with the absorption of polyphenols.
• Frequently using prebiotics, probiotics, yogurt, and/or fiber supplements.
• Pregnant, breastfeeding, or unwilling to practice birth control during study participation.
• Presence of a condition or abnormality that, in the opinion of the investigator, would compromise participant safety or data quality.
• 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.
• Any unstable medical conditions or terminal diagnosis.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoping Li

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Zelicha, PhD, MS, RD

CONTACT

310-206-8292; uclanutrition@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

US (1)