Effect of Supplement on Appetite and GLP-1

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

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.

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.

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.