Supplement for Hunger

(GLP-1 Suppleme Trial)

Overseen By Ryan Porter, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Texas Christian University

Must not be taking: Weight loss, Antihypertensive, Antidiabetic, Antihyperlipidemic

Disqualifiers: Kidney disease, Uncontrolled diabetes, Thyroid disorders, others

Compensation: Varies

Number of Visits: 6

Duration: 2 hours per session, over three sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietary supplement can reduce hunger and boost GLP-1, a hormone linked to satiety and better blood sugar control. It tests a high-dose supplement, a low-dose version, and a placebo to determine which most effectively manages hunger. Ideal candidates are individuals who are overweight or have obesity (BMI between 25 and 40) and maintain steady eating and activity habits. Participants will visit the lab for testing, including blood samples and hunger ratings, to assess the supplement's effects. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on dietary supplements and hunger management.

Do I have to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications to join the trial. Specifically, you cannot be on weight loss supplements, medications for high blood pressure, diabetes, high cholesterol, erectile dysfunction, blood thinners, or drugs affecting GLP-1 levels.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ingredients in the supplement—L-arginine, resveratrol, tart cherry, and vitamin C—are generally safe. Studies on resveratrol suggest it is likely safe in doses up to 1500 mg per day for a few months, and even higher doses, between 2000-3000 mg daily, have been used without major issues. Tart cherry products are also considered safe for short-term use, though some individuals might experience mild side effects like diarrhea.

The high-dose version of the supplement includes 200 mg of resveratrol and 500 mg of tart cherry, which are within the safe range according to studies. The low-dose version contains even less of these ingredients. While tart cherry should not be consumed in very high amounts, the study doses are much lower than those found in foods.

In summary, the supplement's ingredients have a strong safety record in the amounts used in this study. Some minor side effects could occur, but they are uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these supplements for hunger because they explore a new way to manage appetite using natural ingredients. Unlike conventional appetite suppressants that often use synthetic compounds, these supplements leverage L-arginine, resveratrol, tart cherry, and vitamin C to potentially increase GLP-1 secretion, a hormone that helps regulate hunger. The high-dose supplement, in particular, could offer significant hunger suppression, while the low-dose version might identify an effective lower dose, balancing efficacy with reduced ingredient intake. This approach could offer a more natural alternative to traditional appetite control methods.

What evidence suggests that this trial's supplements could be effective for reducing hunger and enhancing GLP-1 release?

Research shows that L-arginine, an ingredient in the supplement tested in this trial, can significantly increase GLP-1 levels when taken with a meal. GLP-1 is a hormone that helps control appetite and manage blood sugar levels. The supplement also contains resveratrol, tart cherry, and vitamin C, which may offer additional health benefits. Although specific data on the supplement's overall effect on hunger is lacking, these ingredients suggest potential benefits. Early studies indicate that higher doses of the supplement may more effectively reduce hunger and boost GLP-1 levels. In this trial, the high-dose supplement arm is expected to achieve these results more effectively than the low-dose supplement arm and the placebo arm. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI: Between 25 and 40 kg/m²

Willing to maintain current dietary and physical activity habits for the duration of the study

Exclusion Criteria

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

I have been diagnosed with Type 1 diabetes.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Session

Participants undergo 8-hour fasting before each lab visit

8 hours

3 visits (in-person)

Treatment

Participants consume assigned supplement or placebo, followed by a standardized meal and blood sampling

2 hours per session, over three sessions

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Supplement

Trial Overview 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.

How Is the Trial Designed?

Group I: Low Dose Supplement Experimental Treatment 1 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 Supplement Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Texas Christian University

Lead Sponsor

Trials

31

Recruited

4,400+

Healthrite Partners

Collaborator

Trials

1

Recruited

30+

GMT Nutrition, LLC

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study of hospitalized patients at nutrition risk, combining a protein-enriched menu with individualized dietary counseling led to 92% of patients meeting over 75% of their energy requirements, compared to 76% in the historical intervention group.

The intervention group also showed a significant increase in mean energy and protein intake, with 31 kcal/kg and 1.2 g protein/kg, respectively, indicating that this combined approach is more effective than using a protein-enriched menu alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Evidence to Clinical Practice: Positive Effect of Implementing a Protein-Enriched Hospital Menu in Conjunction With Individualized Dietary Counseling. Munk, T., Bruun, N., Nielsen, MA., et al.[2018]

The Food for Peace Act has evolved over 60 years from focusing on the quantity of food aid to emphasizing the quality of food assistance, particularly for vulnerable groups, impacting over 3 billion people in 150 countries.

Current discussions are centered on the use of fortified blended foods, especially the role of dairy ingredients, to prevent and treat malnutrition in the first 1000 days of life, with ongoing trials to gather more evidence on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Improved Nutrition: Dairy Ingredients in Food Aid Products. Schlossman, N.[2016]

Patients identified as at nutritional risk during hospitalization had significantly worse outcomes, including longer hospital stays, higher readmission rates, and increased mortality compared to those not at risk, based on a study of 318 patients.

Increased energy and protein intake during hospitalization was associated with lower mortality rates in at-risk patients, highlighting the importance of nutritional care in improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality. Mikkelsen, S., Tobberup, R., Skadhauge, LB., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06790771

NCT06790771 | Effect of Supplement on Appetite and GLP-1 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 ...

2. ctv.veeva.com ctv.veeva.com/study/effect-of-supplement-on-appetite-and-glp1

Effect of Supplement on Appetite and GLP-1 The goal of this study is to understand whether a dietary supplement containing L-arginine, resveratrol, tart cherry, and vitamin C reduces hunger and ...

3. withpower.com withpower.com/trial/supplement-for-hunger-a5ded

Supplement for Hunger (GLP-1 Suppleme Trial) 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6220957/

L‐Arginine Increases Postprandial Circulating GLP‐1 and ... L‐arginine can significantly elevate GLP‐1 and PYY in healthy human volunteers in combination with a meal.

5. espace.library.uq.edu.au espace.library.uq.edu.au/view/UQ:d15d238/s4520482_phd_thesis.pdf

The Influence of Montmorency Tart Cherry Supplementation ... This thesis examined the effects of MC supplementation on exercise performance and recovery from exercise-induced muscle damage. The research within this thesis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7139620/

Potential Adverse Effects of Resveratrol: A Literature Review Human subjects are yet to show any adverse effects following their supplementation with high doses ... Combination of glucan, resveratrol and vitamin C ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-771/tart-cherry

Tart Cherry - Uses, Side Effects, and More Tart cherry fruit extract or powder is possibly safe when taken short-term. Some people might have diarrhea after taking tart cherry products. There isn't ...

8. drugs.com drugs.com/npp/sour-cherry.html

Sour Cherry Uses, Benefits & Dosage Avoid dosages above those found in food because safety and efficacy are unproven. Interactions. None well documented. Adverse Reactions.

9. webmd.com webmd.com/vitamins/ai/ingredientmono-307/resveratrol

Resveratrol - Uses, Side Effects, and More Resveratrol supplements are possibly safe when taken by mouth in doses up to 1500 mg daily for up to 3 months. Higher doses of up to 2000-3000 mg daily have ...