Health TrialsbyHealthPanel

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

ConditionsObesity & OverweightMuscle Mass and StrengthMuscle Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Arm 1 - Standard of CareNo intervention 0 interventions
Group B: Protein Supplementation + PlaceboPlacebo comparator 2 interventions
Group C: Protein Supplementation + Mixed SpicesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months, and 6 months
2

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.

Time frame
Baseline and 6 months

Secondary outcomes

1

Change in 400-Meter Walk Test Performance

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

Time frame
Baseline, 1 month, 3 months, and 6 months
2

Change in Stair Climbing Test Performance

Muscle function will be assessed using a stair climbing test.

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

Change in Grip Strength

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.

Time frame
Baseline, 1 month, 3 months, and 6 months
4

Change in Mitochondrial Function

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

Time frame
Baseline, 3 months, and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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