Effect of Supplement on Appetite and GLP-1

NCT06790771 | Not Yet Recruiting

• 1 other identifier: TCU GLP-1 Study
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. The study will also explore the metabolic effects of the supplement. Main Questions:

• 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.

Conditions

Hunger

Keywords

Hunger; GLP-1; Satiety; Supplement

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

  Single meal during each session, measured in three sessions over three weeks.

• Blood Glucose

  This measure tracks changes in blood glucose concentrations at the same eight time points (baseline, 15, 30, 45, 60, 90, 105, and 120 minutes) as GLP-1 sampling. It evaluates the impact of the supplement on glucose regulation following supplementation and meal intake.

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

Secondary Outcomes (2)

• Insulin Levels

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

• Lipid Profile Levels

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

Study Arms (3)

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.

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.

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.

Dietary Supplement: Low Dose Supplement

Interventions

High Dose Supplement DIETARY_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.

High Dose Supplement

Low Dose Supplement DIETARY_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.

Low Dose Supplement

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Christian University: lead
• Healthrite Partners: collaborator
• GMT Nutrition, LLC: collaborator

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (11)

• 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.

  PMID: 16772327 BACKGROUND

• Dashtabi 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.

  PMID: 26889456 BACKGROUND

• Rogers 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.

  PMID: 37417662 BACKGROUND

• Ceriello 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.

  PMID: 23806096 BACKGROUND

• Hooper 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.

  PMID: 34126996 BACKGROUND

• Bordage 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.

  PMID: 27776374 BACKGROUND

• Kim 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.

  PMID: 33805724 BACKGROUND

• Huang 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.

  PMID: 31666589 BACKGROUND

• Hurt 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.

  PMID: 24409974 BACKGROUND

• Amin 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.

  PMID: 30358156 BACKGROUND

• Clemmensen 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.

  PMID: 23959939 BACKGROUND

Central Study Contacts

Elisa Marroquin, PhD

CONTACT

469-491-6443; E.Marroquin@tcu.edu

Ryan Porter, PhD

CONTACT

817-257-6868; r.porter@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blinded study, meaning neither the participants, researchers, nor analysts will know which condition is being tested during each visit
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each participant will undergo the three experimental conditions in random order. Each intervention will be separated by a wash out period of 1 week.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 24, 2025
• Study Start: January 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after the publication of the primary results and for up to 24 months following the completion of the study.
• Access Criteria: Access to the Individual Participant Data (IPD) and supporting information will be granted to: Qualified Researchers: Academic or clinical researchers affiliated with recognized institutions who request the data for scientific purposes and demonstrate a legitimate interest in advancing the study's objectives. Regulatory Bodies and Sponsors: Regulatory agencies (e.g., IRB and IBC) and study sponsors (sponsors) may access de-identified data for verification, compliance, or reporting purposes. Journal Reviewers: Summary data and de-identified results may be shared during manuscript submission and peer review. What Will Be Shared? * De-identified GLP-1 levels, hunger ratings, food intake, glucose levels, insulin levels, lipid profiles, and session compliance data. * Supporting Documentation: study protocol, statistical analysis plan, and metadata necessary for interpreting the datasets. * Summarized outcomes (e.g., means, SD) for each intervention arm may also be shared.

Locations

US (1)