A Randomized, Double-blind, Placebo-controlled, Crossover, Single-center, Proof of Concept Study to Evaluate the Efficacy of GoodIdea® on Glucose Homeostasis in a Healthy Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
研究概览
简要总结
It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 to 50 years of age
- •BMI 25-29.9 (±0.5) kg/m²
- •Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
- •Healthy as determined by medical history and information provided by the volunteer
- •Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •Elevated fasting blood glucose (at or above 6.1 mmol/L)
- •Women who are pregnant or breast feeding
- •Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- •Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the qualified investigator (QI). Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
- •Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- •Use of antibiotics within 2 weeks of enrollment
- •Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- •Allergy to ingredients included in investigational product, placebo or standardized meal
- •Participants restricted to a vegetarian or vegan diet
- •Intolerance to lactose or gluten
- •Individuals who are averse to venous catheterization or capillary blood sampling
- •Currently active smokers (or using other tobacco products, and e-cigarettes)
- •Unstable medical conditions as determined by QI
- •Participation in other clinical research trials
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Acute infection
- •Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
研究组 & 干预措施
Water with amino acids and chromium
The carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses.
干预措施: Carbonated water with amino acids and chromium (Dietary Supplement)
Carbonated water
The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses.
干预措施: Placebo Carbonated Water (Dietary Supplement)
结局指标
主要结局
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
时间窗: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
次要结局
- The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes(0, 15, 30, 45 and 60 minutes post test meal)
- The three hour iAUC for intravenous glucose, 0-180 minutes(0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal)
- The three-hour iAUC for insulin, 0-180 minutes(0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal)