Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Postprandial Hyperglycemia, Metabolic Syndrome, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Carbonated water with amino acids and chromium
* Dietary Supplement: Placebo Carbonated Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water with amino acids and chromium<br>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. | Dietary Supplement: Carbonated water with amino acids and chromium<br>* The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes<br>|
| Placebo Comparator: Carbonated water<br>The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses. | Dietary Supplement: Placebo Carbonated Water<br>* The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes | 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. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The three-hour iAUC for insulin, 0-180 minutes | The incremental area under the curve for intravenous blood insulin will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal | 
| The three hour iAUC for intravenous glucose, 0-180 minutes | The incremental area under the curve for intravenous 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. | 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal | 
| The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes | The incremental area under the curve for intravenous blood GLP-1 will be measured within 60 minutes after a test meal. Blood samples will be collected at 5 time points during the 60 minutes. | 0, 15, 30, 45 and 60 minutes post test meal |