Effect of Supplement on Appetite and GLP-1

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.

Eligibility Criteria:
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.