Acute Effect of Supplement Containing L-Arginine on Appetite Suppression and GLP-1 Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Appetite
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a triple-blinded study, meaning neither the participants, researchers, nor analysts will know which condition is being tested during each visit
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Placebo
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.
干预措施: Placebo (Dietary Supplement)
High Dose Supplement
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.
干预措施: High Dose Supplement (Dietary Supplement)
Low Dose Supplement
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.
干预措施: Low Dose Supplement (Dietary Supplement)
结局指标
主要结局
Appetite
时间窗: 2 hours per session, measured during three separate sessions over three weeks.
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.
Food Intake
时间窗: Single meal during each session, measured in three sessions over three weeks.
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.
Blood Glucose
时间窗: 2 hours per session, measured during three separate sessions over three weeks.
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.
次要结局
- 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.)
研究者
Elisa Marroquin
Assistant Professor
Texas Christian University