Effect of Supplement on Appetite and GLP-1 (GLP-1 Suppleme)

Texas Christian University

Status: Not yet enrolling

Conditions: Hunger

Treatments: Dietary Supplement: High Dose Supplement; Dietary Supplement: Placebo; Dietary Supplement: Low Dose Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06790771

TCU GLP-1 Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants must meet all the following conditions to be eligible for the study:

• Age: 18-60 years old.
• BMI (Body Mass Index): Between 25 and 40 kg/m².
• Diet and Activity Stability: Willing to maintain current dietary and physical activity habits for the duration of the study.

Exclusion criteria

Participants will be excluded from the study if any of the following conditions apply:

• Recent Weight Change: Lost or gained more than 5% of body weight in the last 3 months.

• Pregnancy or Lactation: Pregnant or breastfeeding women.

• Medical Conditions:

  • Kidney disease (Chronic Kidney Disease or End-Stage Renal Disease).
  • Herpes simplex.
  • Uncontrolled diabetes (HbA1c >7%).
  • Thyroid disorders or taking thyroid medications.
  • Type 1 diabetes.
  • Cushing syndrome.
  • Cirrhosis or hepatitis.
  • Chronic obstructive pulmonary disease (COPD).
  • Dementias.
  • Active autoimmune diseases (e.g., lupus, rheumatoid arthritis).
  • Crohn's disease or ulcerative colitis.
  • Celiac disease.
  • Allergies or Sensitivities:
  • Known allergies to any components of the supplement or standardized meal.
  • Medications: Currently taking any of the following:

• Supplements or medications for weight loss.

• Antihypertensive, antidiabetic, or antihyperlipidemic medications.

• Erectile dysfunction medications.

• Blood thinners (e.g., aspirin, warfarin).

• Medications containing nitric oxide or nitroglycerin.

• Drugs affecting GLP-1 levels, such as GLP-1 receptor agonists, insulin, certain antidepressants, or corticosteroids.

  • Substance Use: Evidence of illegal drug use, including marijuana.
  • Participation in Other Studies: Enrollment in another clinical trial that could interfere with the study outcomes.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The placebo arm serves as the control condition, using a \~5 g powder with no active ingredients. Participants follow the same protocol as the other arms, including an 8-hour fasting period, baseline blood sample collection, and consumption of the placebo before a 60-minute rest. They then eat the standardized meal ad libitum (within a time window of 30 minutes), with blood samples collected at the eight time points and hunger levels assessed using the 7-point scale. The placebo arm is expected to show minimal or no effect on GLP-1 secretion and hunger suppression, providing a baseline for comparison against the two active supplement doses.

Treatment:

Dietary Supplement: Placebo

High Dose Supplement

Experimental group

Description:

In the high-dose supplement arm, participants consume approximately 10 grams of the nutritional supplement, which contains 9,000 mg of L-arginine, 200 mg of resveratrol, 500 mg of tart cherry, and 100 mg of vitamin C. After an 8-hour fasting period, participants visit the lab, where a baseline blood sample is collected before supplement consumption. They then rest for 60 minutes to allow absorption and subsequently eat a standardized meal (Bertolli Chicken Alfredo pasta bake) ad libitum within 30 minutes. Blood samples are collected at eight time points, and hunger levels are measured using a 7-point satiety scale. This arm is expected to show the most pronounced effects on GLP-1 secretion and hunger suppression compared to the other arms, highlighting the potential efficacy of a high-dose intervention.

Treatment:

Dietary Supplement: High Dose Supplement

Low Dose Supplement

Experimental group

Description:

In the low-dose supplement arm, participants consume approximately 5 grams of the supplement, consisting of 4,500 mg of L-arginine, 100 mg of resveratrol, 250 mg of tart cherry, and 50 mg of vitamin C. As in the high-dose arm, participants arrive after fasting for 8 hours, provide a baseline blood sample, and consume the supplement before a 60-minute rest. Following the rest period, they eat the same standardized meal ad libitum within a time window of 30 minutes. Blood samples are again taken at eight time points, and hunger levels are recorded using the same scale. This arm evaluates whether a reduced dose of the supplement provides moderate effects on GLP-1 secretion and hunger suppression, potentially identifying a lower effective dose.

Treatment:

Dietary Supplement: Low Dose Supplement