NCT06790771

Effect of Supplement on Appetite and GLP-1

Acute Effect of Supplement Containing L-Arginine on Appetite Suppression and GLP-1 Induction

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Texas Christian University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Title: Acute Effect of Supplement Containing L-Arginine on Appetite Suppression and GLP-1 Induction Research Objectives: The study aims to evaluate the effects of a dietary supplement containing L-arginine, resveratrol, tart cherry, and vitamin C on appetite suppression, GLP-1 hormone release, and associated metabolic outcomes in individuals with overweight or obesity. Background: GLP-1 (Glucagon-Like Peptide 1) plays a crucial role in regulating appetite and glucose homeostasis. Condensed Background Information: The combination of the following ingredients is hypothesized to have a synergistic effect, promoting satiety and improving metabolic health: * L-arginine enhances GLP-1 secretion, improving glucose tolerance and reducing appetite. * Resveratrol inhibits DPP-IV, extending the activity of GLP-1. * Tart cherry supports metabolic regulation by enhancing nitric oxide availability and preventing arginine catabolism. * Vitamin C acts as an antioxidant, supporting the efficacy of other components. Participant Details: * Number of Participants: 25 * Eligibility Criteria: * Adults aged 18-60 years. * BMI between 25 and 40 kg/m². * Must maintain current diet and physical activity levels. Exclusion Criteria: * Significant weight change (\>5%) in the last three months. * Medical conditions like uncontrolled diabetes, kidney disease, thyroid disorders, or autoimmune diseases. * Current use of medications or supplements affecting weight or GLP-1 levels. * Pregnancy or lactation. Study Design: This is a randomized, triple-blinded, placebo-controlled study with three conditions: * High-Dose Supplement (\~10 g) * Low-Dose Supplement (\~5 g) * Placebo (\~5 g) Each participant will experience all three conditions in random order. The timeline for the study involves: * Pre-Session: 8-hour fasting before each visit. * Arrival at the lab (Rickel Building, Rooms 256/259). * Baseline blood sample collection. * Administration of assigned supplement/placebo. * 60-minute rest period. * Consumption of a standardized meal (Bertolli Chicken Alfredo pasta bake) in isolation within a 30-minute window. * Collection of additional blood samples at eight-time points * Measurement of hunger using a 7-point scale. Study Procedures Blood Sampling: * 7 mL samples collected at each time point for metabolic analysis (e.g., glucose, insulin, GLP-1). * Total blood volume: 168 mL per participant across all sessions. * Samples will be analyzed for metabolic markers in Dr. Ryan Porter's lab. Satiety Measurement: Participants will rate hunger levels at each blood draw using a scale from "Extremely Hungry" to "Extremely Full." Meal Intake: An ad libitum meal is provided to assess the impact of supplementation on food consumption. Risks and Mitigation * Blood Draw Risks: Bruising, pain, infection, or dizziness. Managed by using trained personnel and aseptic techniques. * Supplement Risks: Gastrointestinal discomfort and allergic reactions. Addressed by pre-screening participants for allergies. Emergency supplies will be available. * Data Privacy Risks: All data will be anonymized and stored securely to prevent breaches. Expected Outcomes The study aims to determine: * If the supplement reduces hunger compared to a placebo. * If it enhances GLP-1 release post-meal. * If it improves other metabolic parameters (e.g., glucose, lipid profiles). Data Handling: All data will be anonymized and securely stored. Samples may be retained for up to 24 months for further research. Statistical Analysis: Data analysis will use ANOVA and Tukey's post-hoc tests in SPSS, with significance set at p\<0.05. Study Impact: This research could contribute to developing effective nutritional interventions to support appetite regulation and weight management, benefiting individuals with obesity and/or metabolic disorders.

Conditions

• Hunger

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-05-15
• Completion: 2025-12-15
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States