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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Supplement for Hunger?

Research shows that oral nutritional supplements (ONS) can improve nutritional status and outcomes in hospitalized patients, such as reducing the risk of mortality and improving energy and protein intake. This suggests that similar supplements might help manage hunger effectively. ^{1 2 3 4 5}

Is the Supplement for Hunger safe for human use?

The studies on similar supplements, like balanced energy protein supplements and ready-to-use therapeutic foods, show they are generally well-tolerated and safe for use in humans, with high acceptability and no significant adverse effects reported. ^{6 7 8 9 10}

How does the Supplement for Hunger treatment differ from other treatments for hunger or malnutrition?

The Supplement for Hunger treatment is unique because it focuses on using enriched or fortified foods as a more appealing alternative to traditional oral nutritional supplements, which may help improve meals and prevent weight loss in malnourished individuals, particularly older adults. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality. [2023]

2. United States 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Energy- and protein intake of surgical patients after the implementation of energy dense hospital menus. [2019]

4. France pubmed.ncbi.nlm.nih.gov

Nutritional support in elderly patients. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of oral nutritional supplementation on hospital outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Home consumption of two fortified balanced energy protein supplements by pregnant women in Burkina Faso. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Compliance with and acceptability of two fortified balanced energy protein supplements among pregnant women in rural Nepal. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Acceptability of locally produced ready-to-use therapeutic foods in Ethiopia, Ghana, Pakistan and India. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

A pilot study assessing the impact of a fortified supplementary food on the health and well-being of crèche children and adult TB patients in South Africa. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Results of High-Protein, High-Calorie Oral Nutritional Supplementation in Malnourished Older People in Nursing Homes: An Observational, Multicenter, Prospective, Pragmatic Study (PROT-e-GER). [2022]

14. France pubmed.ncbi.nlm.nih.gov

Effectiveness of Food-Based Fortification in Older People. A Systematic Review and Meta-Analysis. [2018]

15. Australia pubmed.ncbi.nlm.nih.gov

Tackling malnutrition with a new compact oral nutrient supplement among residents in aged care: a pilot study. [2023]