UCLA Center for Human Nutrition
Los Angeles, California, 90024, United States
Location status: Recruiting
NCT Number: NCT07806838
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90024, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.
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.
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.
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Muscle function will be assessed using the 400-meter walk test.
Time frame: Baseline, 1 month, 3 months, and 6 months
Muscle function will be assessed using a stair climbing test.
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.
Time frame: Baseline, 3 months, and 6 months
Mitochondrial function will be assessed in peripheral blood mononuclear cells (PBMCs), including autophagy and mitochondrial assays.
Time frame: Baseline, 3 months, and 6 months
Fasting glucose will be measured to assess glucose homeostasis.
Time frame: Time Frame: Baseline to 6 months
Fasting insulin will be measured to assess insulin sensitivity.
Time frame: Baseline, 3 months, and 6 months
Description: Fasting C-peptide will be measured as a marker of pancreatic beta-cell function.
Time frame: Baseline, 3 months, and 6 months
Description: Fasting glucagon will be measured as a metabolic marker.
Time frame: Baseline, 3 months, and 6 months
Fasting GIP will be measured to evaluate metabolic pathways related to glucose regulation.
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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Time frame: Baseline, 1 month, 3 months, and 6 months
Body composition will be assessed using an InBody bioelectrical
Time frame: Baseline, 1 month, 3 months, and 6 months
Fatigue will be assessed using the PROMIS Fatigue Short Form 8-item questionnaire.
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).
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.
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.
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.
Time frame: Baseline and 6 months
Gut microbiome composition will be assessed using fecal samples
Contact information is provided by the study sponsor or research team.
University of California, Los Angeles
Other
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
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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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