Effect of Supplement on Appetite and GLP-1
NCT06790771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-01-24
Summary
Study Summary
The goal of this study is to understand whether a dietary supplement containing L-arginine, resveratrol, tart cherry, and vitamin C reduces hunger and increases the release of GLP-1, a hormone associated with appetite suppression and improved glucose regulation. The study will also explore the metabolic effects of the supplement.
Main Questions:
1. Does the supplement reduce hunger more effectively than a placebo?
2. Does it enhance GLP-1 release in individuals with overweight or obesity?
Participants:
* Age: 18-60 years
* Body Mass Index (BMI): 25-40 kg/m²
* Total participants: 25
* Must maintain usual eating and activity habits during the study.
Study Design:
* Conditions Tested: High-dose supplement, low-dose supplement, and placebo.
* Participants will undergo three separate 2-hour lab visits, each after fasting for 8 hours.
* During each visit:
* Consume the assigned supplement or placebo.
* Eat a standardized meal after a 60-minute rest.
* Provide blood samples at eight time points to measure GLP-1 and other metabolic markers.
* Rate hunger using a 7-point scale.
Benefits and Risks:
* Benefits: Participants may not directly benefit, but the findings could lead to new appetite-suppressing supplements that aid in weight loss.
* Risks: Include discomfort from blood draws, possible gastrointestinal side effects from the supplement, and allergic reactions. Measures are in place to minimize these risks, such as pre-screening for allergies and using trained personnel for blood collection.
This study is triple-blinded, meaning neither the participants, researchers, nor analysts will know which condition is being tested during each visit. Data collected will be anonymized to protect participant privacy.
Conditions
- Hunger
Interventions
- DIETARY_SUPPLEMENT
-
High Dose Supplement
Participants in this intervention receive approximately 10 grams of the supplement, containing 9,000 mg of L-arginine, 200 mg of resveratrol, 500 mg of tart cherry, and 100 mg of vitamin C. The supplement is consumed in powdered form after an 8-hour fasting period. Following a 60-minute rest, participants eat an ad libitum meal to assess the supplement's effect on hunger and food intake. Blood samples are collected at eight specific time points to measure metabolic markers, including GLP-1 levels, while hunger is tracked using a 7-point satiety scale. This intervention aims to determine the effects of a high dose of the supplement on appetite suppression and metabolic responses.
- DIETARY_SUPPLEMENT
-
Low Dose Supplement
In this intervention, participants consume approximately 5 grams of the supplement, which contains 4,500 mg of L-arginine, 100 mg of resveratrol, 250 mg of tart cherry, and 50 mg of vitamin C. The protocol mirrors that of the high-dose intervention: participants arrive after fasting for 8 hours, consume the supplement, rest for 60 minutes, and eat the standardized ad libitum meal. Blood samples are taken at the same eight time points to assess metabolic responses, and hunger levels are measured using the same satiety scale. This intervention investigates whether a lower dose of the supplement can still significantly affect hunger and GLP-1 secretion.
- DIETARY_SUPPLEMENT
-
Placebo
The placebo intervention involves participants consuming a \~5 g inert powder with no active ingredients. Participants follow the same protocol as the other two interventions, including fasting, baseline blood collection, supplement (placebo) consumption, a 60-minute rest, and an ad libitum meal. Blood samples are collected at eight time points, and hunger levels are assessed with the 7-point scale. This intervention serves as a control, helping to determine whether observed effects in the other two interventions are attributable to the active supplement ingredients.
Sponsors & Collaborators
-
Healthrite Partners
collaborator UNKNOWN -
GMT Nutrition, LLC
collaborator UNKNOWN -
Texas Christian University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-15
- Primary Completion
- 2025-05-15
- Completion
- 2025-12-15
Countries
- United States
Study Locations
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