HungerGLP-1 SupplemeNCT06790771
Effect of Supplement on Appetite and GLP-1
A study testing High Dose Supplement and Low Dose Supplement in people with Hunger, run by Texas Christian University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hunger
- What is being tested?
- High Dose Supplement and Low Dose Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Supplement Containing L-Arginine on Appetite Suppression and GLP-1 Induction
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.
Read more
Main Questions:
- Does the supplement reduce hunger more effectively than a placebo?
- 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.
Read the detailed description
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.
- Conditions
- Hunger
- Being tested
- High Dose Supplement, Low Dose Supplement, Placebo
- Keywords
- Hunger, GLP-1, Satiety, Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose SupplementDietary supplement
Participants in this intervention receive approximately 10 grams of the supplement, containing 9,000 mg of L-arginine, 200 mg of resveratrol, 500 mg of tart cherry, and 100 mg of vitamin C. The supplement is consumed in powdered form after an 8-hour fasting period. Following a 60-minute rest, participants eat an ad libitum meal to assess the supplement's effect on hunger and food intake. Blood samples are collected at eight specific time points to measure metabolic markers, including GLP-1 levels, while hunger is tracked using a 7-point satiety scale. This intervention aims to determine the effects of a high dose of the supplement on appetite suppression and metabolic responses.
Low Dose SupplementDietary supplement
In this intervention, participants consume approximately 5 grams of the supplement, which contains 4,500 mg of L-arginine, 100 mg of resveratrol, 250 mg of tart cherry, and 50 mg of vitamin C. The protocol mirrors that of the high-dose intervention: participants arrive after fasting for 8 hours, consume the supplement, rest for 60 minutes, and eat the standardized ad libitum meal. Blood samples are taken at the same eight time points to assess metabolic responses, and hunger levels are measured using the same satiety scale. This intervention investigates whether a lower dose of the supplement can still significantly affect hunger and GLP-1 secretion.
PlaceboDietary supplement
The placebo intervention involves participants consuming a ~5 g inert powder with no active ingredients. Participants follow the same protocol as the other two interventions, including fasting, baseline blood collection, supplement (placebo) consumption, a 60-minute rest, and an ad libitum meal. Blood samples are collected at eight time points, and hunger levels are assessed with the 7-point scale. This intervention serves as a control, helping to determine whether observed effects in the other two interventions are attributable to the active supplement ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| High Dose Supplement | Experimental | 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. Receives: Dietary Supplement: High Dose Supplement |
| Low Dose Supplement | Experimental | 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. Receives: Dietary Supplement: Low Dose Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
This measure tracks changes in blood GLP-1 concentrations at eight time points (baseline, 15, 30, 45, 60, 90, 105, and 120 minutes).
Measured: 2 hours per session, measured during three separate sessions over three weeks.
Secondary outcomes (2)
Food Intake
This measure evaluates the amount of food consumed during the ad libitum standardized meal provided at each session. Participants will eat until they feel comfortably full, and the total food intake will be weighed to assess the impact of the interventions on caloric consumption.
Measured: Single meal during each session, measured in three sessions over three weeks.
Appetite
This measure tracks participants' subjective hunger levels using a validated 7-point satiety scale (ranging from "Extremely Hungry" to "Extremely Full"). Ratings will be recorded at each of the eight time points corresponding to blood sample collection to assess the effect of the supplement on appetite suppression.
Measured: 2 hours per session, measured during three separate sessions over three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HungerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will undergo the three experimental conditions in random order. Each intervention will be separated by a wash out period of 1 week.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Healthrite Partners, GMT Nutrition, LLC
- Responsible party
- Principal investigator, Elisa Marroquin, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790771
- Sponsor's protocol ID
- TCU GLP-1 Study
- Acronym
- GLP-1 Suppleme
- Status last verified
- May 2026
- First submitted
- 7 Jan 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specific IPD That Can Be Shared Demographic Data: * Age * Sex Anthropometric Data: \- BMI Outcome Measures: * GLP-1 levels * Hunger ratings * Food intake data (grams or kcal) * Blood glucose levels * Insulin levels * Lipid profile markers Adverse Events or Side Effects: * Reports of gastrointestinal distress or other reactions to the supplement * Any issues related to blood sampling Session Attendance and Compliance: * Adherence to fasting requirements * Completion of all study sessions Conditions for Sharing IPD De-Identification: Investigators will remove all personal identifiers (e.g., name, contact information, date of birth). Data Aggregation: Investigators will aggregate data if necessary to prevent re-identification of participants. Access Control: Share data only with authorized researchers who request it or for peer-reviewed publications. Informed Consent: Investigators will ensure participants are aware and have agreed to the potential sharing of de-identified data.
Publications
Lucotti P, Setola E, Monti LD, Galluccio E, Costa S, Sandoli EP, Fermo I, Rabaiotti G, Gatti R, Piatti P. Beneficial effects of a long-term oral L-arginine treatment added to a hypocaloric diet and exercise training program in obese, insulin-resistant type 2 diabetic patients. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E906-12. doi: 10.1152/ajpendo.00002.2006. Epub 2006 Jun 13.
PubMed 16772327Dashtabi A, Mazloom Z, Fararouei M, Hejazi N. Oral L-Arginine Administration Improves Anthropometric and Biochemical Indices Associated With Cardiovascular Diseases in Obese Patients: A Randomized, Single Blind Placebo Controlled Clinical Trial. Res Cardiovasc Med. 2015 Dec 29;5(1):e29419. doi: 10.5812/cardiovascmed.29419. eCollection 2016 Feb.
PubMed 26889456Rogers DR, Lawlor DJ, Moeller JL. Vitamin C Supplementation and Athletic Performance: A Review. Curr Sports Med Rep. 2023 Jul 1;22(7):255-259. doi: 10.1249/JSR.0000000000001083.
PubMed 37417662Ceriello A, Novials A, Ortega E, Canivell S, Pujadas G, La Sala L, Bucciarelli L, Rondinelli M, Genovese S. Vitamin C further improves the protective effect of GLP-1 on the ischemia-reperfusion-like effect induced by hyperglycemia post-hypoglycemia in type 1 diabetes. Cardiovasc Diabetol. 2013 Jun 27;12:97. doi: 10.1186/1475-2840-12-97.
PubMed 23806096Hooper DR, Orange T, Gruber MT, Darakjian AA, Conway KL, Hausenblas HA. Broad Spectrum Polyphenol Supplementation from Tart Cherry Extract on Markers of Recovery from Intense Resistance Exercise. J Int Soc Sports Nutr. 2021 Jun 14;18(1):47. doi: 10.1186/s12970-021-00449-x.
PubMed 34126996Bordage S, Pham TN, Zedet A, Gugglielmetti AS, Nappey M, Demougeot C, Girard-Thernier C. Investigation of Mammal Arginase Inhibitory Properties of Natural Ubiquitous Polyphenols by Using an Optimized Colorimetric Microplate Assay. Planta Med. 2017 May;83(7):647-653. doi: 10.1055/s-0042-118711. Epub 2016 Oct 24.
PubMed 27776374Kim DW, Jung DH, Sung J, Min IS, Lee SJ. Tart Cherry Extract Containing Chlorogenic Acid, Quercetin, and Kaempferol Inhibits the Mitochondrial Apoptotic Cell Death Elicited by Airborne PM10 in Human Epidermal Keratinocytes. Antioxidants (Basel). 2021 Mar 13;10(3):443. doi: 10.3390/antiox10030443.
PubMed 33805724Huang PK, Lin SR, Chang CH, Tsai MJ, Lee DN, Weng CF. Natural phenolic compounds potentiate hypoglycemia via inhibition of Dipeptidyl peptidase IV. Sci Rep. 2019 Oct 30;9(1):15585. doi: 10.1038/s41598-019-52088-7.
PubMed 31666589Hurt RT, Ebbert JO, Schroeder DR, Croghan IT, Bauer BA, McClave SA, Miles JM, McClain CJ. L-arginine for the treatment of centrally obese subjects: a pilot study. J Diet Suppl. 2014 Mar;11(1):40-52. doi: 10.3109/19390211.2013.859216. Epub 2014 Jan 10.
PubMed 24409974Amin A, Neophytou C, Thein S, Martin NM, Alamshah A, Spreckley E, Bloom SR, Murphy KG. L-Arginine Increases Postprandial Circulating GLP-1 and PYY Levels in Humans. Obesity (Silver Spring). 2018 Nov;26(11):1721-1726. doi: 10.1002/oby.22323.
PubMed 30358156Clemmensen C, Smajilovic S, Smith EP, Woods SC, Brauner-Osborne H, Seeley RJ, D'Alessio DA, Ryan KK. Oral L-arginine stimulates GLP-1 secretion to improve glucose tolerance in male mice. Endocrinology. 2013 Nov;154(11):3978-83. doi: 10.1210/en.2013-1529. Epub 2013 Aug 19.
PubMed 23959939
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Supplement Containing L-Arginine on Appetite Suppression and GLP-1 Induction
- ClinicalTrials.gov ID
- NCT06790771
- Acronym / sponsor ID
- GLP-1 Suppleme / TCU GLP-1 Study
- Conditions
- Hunger
- Keywords
- Hunger, GLP-1, Satiety, Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- Healthrite Partners, GMT Nutrition, LLC
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the supplement reduce hunger more effectively than a placebo?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant will undergo the three experimental conditions in random order. Each intervention will be separated by a wash out period of 1 week.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
| High Dose Supplement | Experimental | Dietary Supplement: High Dose SupplementIn 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. |
| Low Dose Supplement | Experimental | Dietary Supplement: Low Dose SupplementIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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:
- Supplements or medications for weight loss.
- Antihypertensive, antidiabetic, or antihyperlipidemic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose SupplementParticipants in this intervention receive approximately 10 grams of the supplement, containing 9,000 mg of L-arginine, 200 mg of resveratrol, 500 mg of tart cherry, and 100 mg of vitamin C. The supplement is consumed in powdered form after an 8-hour fasting period. Following a 60-minute rest, participants eat an ad libitum meal to assess the supplement's effect on hunger and food intake. Blood samples are collected at eight specific time points to measure metabolic markers, including GLP-1 levels, while hunger is tracked using a 7-point satiety scale. This intervention aims to determine the effects of a high dose of the supplement on appetite suppression and metabolic responses. | Dietary supplement | High Dose Supplement |
| Low Dose SupplementIn this intervention, participants consume approximately 5 grams of the supplement, which contains 4,500 mg of L-arginine, 100 mg of resveratrol, 250 mg of tart cherry, and 50 mg of vitamin C. The protocol mirrors that of the high-dose intervention: participants arrive after fasting for 8 hours, consume the supplement, rest for 60 minutes, and eat the standardized ad libitum meal. Blood samples are taken at the same eight time points to assess metabolic responses, and hunger levels are measured using the same satiety scale. This intervention investigates whether a lower dose of the supplement can still significantly affect hunger and GLP-1 secretion. | Dietary supplement | Low Dose Supplement |
| PlaceboThe placebo intervention involves participants consuming a ~5 g inert powder with no active ingredients. Participants follow the same protocol as the other two interventions, including fasting, baseline blood collection, supplement (placebo) consumption, a 60-minute rest, and an ad libitum meal. Blood samples are collected at eight time points, and hunger levels are assessed with the 7-point scale. This intervention serves as a control, helping to determine whether observed effects in the other two interventions are attributable to the active supplement ingredients. | Dietary supplement | Placebo |
Primary outcome
GLP-1
Time frame: 2 hours per session, measured during three separate sessions over three weeks.
This measure tracks changes in blood GLP-1 concentrations at eight time points (baseline, 15, 30, 45, 60, 90, 105, and 120 minutes).
2 secondary outcomes
Food Intake
Time frame: Single meal during each session, measured in three sessions over three weeks.
Appetite
Time frame: 2 hours per session, measured during three separate sessions over three weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 16772327Lucotti P, Setola E, Monti LD, Galluccio E, Costa S, Sandoli EP, Fermo I, Rabaiotti G, Gatti R, Piatti P. Beneficial effects of a long-term oral L-arginine treatment added to a hypocaloric diet and exercise training program in obese, insulin-resistant type 2 diabetic patients. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E906-12. doi: 10.1152/ajpendo.00002.2006. Epub 2006 Jun 13.
- Background: PubMed 26889456Dashtabi A, Mazloom Z, Fararouei M, Hejazi N. Oral L-Arginine Administration Improves Anthropometric and Biochemical Indices Associated With Cardiovascular Diseases in Obese Patients: A Randomized, Single Blind Placebo Controlled Clinical Trial. Res Cardiovasc Med. 2015 Dec 29;5(1):e29419. doi: 10.5812/cardiovascmed.29419. eCollection 2016 Feb.
- Background: PubMed 37417662Rogers DR, Lawlor DJ, Moeller JL. Vitamin C Supplementation and Athletic Performance: A Review. Curr Sports Med Rep. 2023 Jul 1;22(7):255-259. doi: 10.1249/JSR.0000000000001083.
- Background: PubMed 23806096Ceriello A, Novials A, Ortega E, Canivell S, Pujadas G, La Sala L, Bucciarelli L, Rondinelli M, Genovese S. Vitamin C further improves the protective effect of GLP-1 on the ischemia-reperfusion-like effect induced by hyperglycemia post-hypoglycemia in type 1 diabetes. Cardiovasc Diabetol. 2013 Jun 27;12:97. doi: 10.1186/1475-2840-12-97.
- Background: PubMed 34126996Hooper DR, Orange T, Gruber MT, Darakjian AA, Conway KL, Hausenblas HA. Broad Spectrum Polyphenol Supplementation from Tart Cherry Extract on Markers of Recovery from Intense Resistance Exercise. J Int Soc Sports Nutr. 2021 Jun 14;18(1):47. doi: 10.1186/s12970-021-00449-x.
- Background: PubMed 27776374Bordage S, Pham TN, Zedet A, Gugglielmetti AS, Nappey M, Demougeot C, Girard-Thernier C. Investigation of Mammal Arginase Inhibitory Properties of Natural Ubiquitous Polyphenols by Using an Optimized Colorimetric Microplate Assay. Planta Med. 2017 May;83(7):647-653. doi: 10.1055/s-0042-118711. Epub 2016 Oct 24.
- Background: PubMed 33805724Kim DW, Jung DH, Sung J, Min IS, Lee SJ. Tart Cherry Extract Containing Chlorogenic Acid, Quercetin, and Kaempferol Inhibits the Mitochondrial Apoptotic Cell Death Elicited by Airborne PM10 in Human Epidermal Keratinocytes. Antioxidants (Basel). 2021 Mar 13;10(3):443. doi: 10.3390/antiox10030443.
- Background: PubMed 31666589Huang PK, Lin SR, Chang CH, Tsai MJ, Lee DN, Weng CF. Natural phenolic compounds potentiate hypoglycemia via inhibition of Dipeptidyl peptidase IV. Sci Rep. 2019 Oct 30;9(1):15585. doi: 10.1038/s41598-019-52088-7.
- Background: PubMed 24409974Hurt RT, Ebbert JO, Schroeder DR, Croghan IT, Bauer BA, McClave SA, Miles JM, McClain CJ. L-arginine for the treatment of centrally obese subjects: a pilot study. J Diet Suppl. 2014 Mar;11(1):40-52. doi: 10.3109/19390211.2013.859216. Epub 2014 Jan 10.
- Background: PubMed 30358156Amin A, Neophytou C, Thein S, Martin NM, Alamshah A, Spreckley E, Bloom SR, Murphy KG. L-Arginine Increases Postprandial Circulating GLP-1 and PYY Levels in Humans. Obesity (Silver Spring). 2018 Nov;26(11):1721-1726. doi: 10.1002/oby.22323.
- Background: PubMed 23959939Clemmensen C, Smajilovic S, Smith EP, Woods SC, Brauner-Osborne H, Seeley RJ, D'Alessio DA, Ryan KK. Oral L-arginine stimulates GLP-1 secretion to improve glucose tolerance in male mice. Endocrinology. 2013 Nov;154(11):3978-83. doi: 10.1210/en.2013-1529. Epub 2013 Aug 19.
- Individual participant dataSharing planned: Yes. Specific IPD That Can Be Shared Demographic Data: * Age * Sex Anthropometric Data: - BMI Outcome Measures: * GLP-1 levels * Hunger ratings * Food intake data (grams or kcal) * Blood glucose levels * Insulin levels * Lipid profile markers Adverse Events or Side Effects: * Reports of gastrointestinal distress or other reactions to the supplement * Any issues related to blood sampling Session Attendance and Compliance: * Adherence to fasting requirements * Completion of all study sessions Conditions for Sharing IPD De-Identification: Investigators will remove all personal identifiers (e.g., name, contact information, date of birth). Data Aggregation: Investigators will aggregate data if necessary to prevent re-identification of participants. Access Control: Share data only with authorized researchers who request it or for peer-reviewed publications. Informed Consent: Investigators will ensure participants are aware and have agreed to the potential sharing of de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Supplement and Low Dose Supplement in people with Hunger, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLP-1 (time frame: 2 hours per session, measured during three separate sessions over three weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790771, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.