NCT07806838 · University of California, Los Angeles
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
What this study is 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
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.
DIETARY_SUPPLEMENT
Maltodextrin Placebo Capsules
Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.
DIETARY_SUPPLEMENT
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 measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2026 · Source of record for eligibility and locations