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Dietary Supplement

Supplement for Hunger (GLP-1 Suppleme Trial)

Fort Worth, TX

N/A

Waitlist Available

Research Sponsored by Texas Christian University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18-60 years old

Be between 18 and 65 years old

Must not have

Lost or gained more than 5% of body weight in the last 3 months

History of Type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours per session, measured during three separate sessions over three weeks.

Summary

This trial aims to determine if a dietary supplement can reduce hunger and increase the release of a hormone associated with appetite suppression. The study will involve 25 participants aged 18-60 with a BMI between

Who is the study for?

This trial is for adults aged 18-60 with a BMI of 25-40 kg/m². Participants should maintain their normal diet and exercise routines during the study. They cannot join if they have allergies that could interfere or conditions affecting blood draw procedures.

What is being tested?

The study tests whether a dietary supplement with L-arginine, resveratrol, tart cherry, and vitamin C affects hunger and GLP-1 hormone levels compared to a placebo. It involves three lab visits where participants fast, consume the test product, eat a meal, then provide blood samples.

What are the potential side effects?

Possible side effects include discomfort from blood draws and gastrointestinal issues like upset stomach due to the supplement. Allergic reactions are also possible but will be minimized by pre-screening participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My weight has changed by more than 5% in the last 3 months.

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I have been diagnosed with Type 1 diabetes.

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I have had Cushing syndrome in the past.

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I have a history of liver disease.

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I have a history of COPD.

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I have a history of kidney disease.

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My diabetes is not under control (HbA1c >7%).

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I have a thyroid condition or take thyroid medication.

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I have a history of Crohn's disease or ulcerative colitis.

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I have been diagnosed with celiac disease.

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I am currently taking medication for weight loss, blood pressure, diabetes, cholesterol, erectile dysfunction, blood thinning, or drugs that affect GLP-1 levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ single meal during each session, measured in three sessions over three weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~single meal during each session, measured in three sessions over three weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and single meal during each session, measured in three sessions over three weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Appetite

Blood Glucose

Food Intake

Secondary study objectives

Insulin Levels

Lipid Profile Levels

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose SupplementExperimental Treatment1 Intervention

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.

Group II: High Dose SupplementExperimental Treatment1 Intervention

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.

Group III: PlaceboPlacebo Group1 Intervention

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.

0 / 12Eligibility criteria met