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NCT Number: NCT07806838

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for Human Nutrition

Los Angeles, California, 90024, United States

Location status: Recruiting

Location contact

Hila Zelicha

CONTACT

[email protected]

310-206-8292

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.
  • Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, or DPP4 as single-agent therapy or combination oral agents.
  • Taking GLP-1 medications for more than 3 months.
  • Have a medical implant or other metal implant, including a pacemaker.
  • Unwilling to stay on a GLP-1 medication for 6 months or for the duration of study participation.

Treatment and study plan

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.

Maltodextrin Placebo Capsules

Dietary Supplement

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

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.

Primary outcomes

  1. Change in Muscle Mass Measured by DEXA

    Time frame: Baseline, 3 months, and 6 months

    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.

  2. Change in Muscle Mass Measured by D3-Creatine Enrichment

    Time frame: Baseline and 6 months

    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.

Secondary outcomes

  1. Change in 400-Meter Walk Test Performance

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Muscle function will be assessed using the 400-meter walk test.

  2. Change in Stair Climbing Test Performance

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Muscle function will be assessed using a stair climbing test.

  3. Change in Grip Strength

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Grip strength will be measured using a handheld dynamometer and recorded in kilograms. The best of three trials for each hand will be used in the analysis.

  4. Change in Mitochondrial Function

    Time frame: Baseline, 3 months, and 6 months

    Mitochondrial function will be assessed in peripheral blood mononuclear cells (PBMCs), including autophagy and mitochondrial assays.

  5. Change in Fasting Glucose

    Time frame: Baseline, 3 months, and 6 months

    Fasting glucose will be measured to assess glucose homeostasis.

  6. Change in Fasting Insulin

    Time frame: Time Frame: Baseline to 6 months

    Fasting insulin will be measured to assess insulin sensitivity.

  7. Change in C-Peptide

    Time frame: Baseline, 3 months, and 6 months

    Description: Fasting C-peptide will be measured as a marker of pancreatic beta-cell function.

  8. Change in Glucagon

    Time frame: Baseline, 3 months, and 6 months

    Description: Fasting glucagon will be measured as a metabolic marker.

  9. Change in Glucose-Dependent Insulinotropic Polypeptide (GIP)

    Time frame: Baseline, 3 months, and 6 months

    Fasting GIP will be measured to evaluate metabolic pathways related to glucose regulation.

  10. Change in High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Time Frame: Baseline, 3 months, and 6 months

    Description: High-sensitivity C-reactive protein will be measured as a marker of systemic inflammation.

  11. Change in Body Weight

    Time frame: Baseline, 1 month, 3 months, and 6 months

  12. Change in Body Composition by Bioelectrical Impedance Analysis

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Body composition will be assessed using an InBody bioelectrical

  13. Change in Fatigue Assessed by PROMIS Fatigue Short Form 8a

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Fatigue will be assessed using the PROMIS Fatigue Short Form 8-item questionnaire.

  14. Change in Quality of Life Assessed by SF-36

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).

  15. Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

  16. Change in Dietary Energy and Macronutrient Intake

    Time frame: Baseline, 1 month, 3 months, 4.5 months, and 6 months

    Dietary energy and macronutrient intake will be assessed using 24-hour dietary recalls.

  17. Change in Physical Activity

    Time frame: Baseline, 1 month, 3 months, 4.5 months, and 6 months

    Physical activity will be monitored using step counts from participants' personal devices and self-reported physical activity recorded using MyNetDiary.

  18. Change in Gut Microbiome Composition

    Time frame: Baseline and 6 months

    Gut microbiome composition will be assessed using fecal samples

Study contacts

Contact information is provided by the study sponsor or research team.

Hila Zelicha, PhD, MS, RD

CONTACT

[email protected]

310-206-8292

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

The Effect of Daily Mixed Spice Consumption and Protein Supplementation on Muscle Mass and Function in Adults Using GLP-1 Agonists for Weight Management: A Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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