GLP-1 SupplemeL-Arginine Supplement for Appetite and GLP-1 in Overweight Adults
High Dose Supplement
+ Low Dose Supplement
+ Placebo
Prevention Study
Summary
Study start date: January 15, 2025
Actual date on which the first participant was enrolled.This study explores how a dietary supplement containing L-arginine, resveratrol, tart cherry, and vitamin C affects hunger and the release of a hormone called GLP-1 in people who are overweight or have obesity. GLP-1 is important for controlling appetite and blood sugar levels. The ingredients in the supplement are thought to work together to help people feel full and improve metabolic health. This research could lead to better ways to manage weight and enhance the health of individuals with obesity or metabolic issues. Participants in this study will try different doses of the supplement and a placebo in a random order. Before each session, they will fast for eight hours, then receive the supplement or placebo. After a short rest, they will eat a standardized meal, and their hunger levels and blood samples will be collected at several points. This helps researchers measure changes in hunger and other metabolic markers like glucose and insulin levels. The main risks include minor issues from blood draws and possible discomfort from the supplement, but these are managed with professional care and safety measures. The study aims to see if the supplement can effectively reduce hunger and improve metabolic indicators compared to a placebo.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location