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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Metabolic Syndrome; Postprandial Hyperglycemia
• Intervention / Treatment: Dietary supplement: Carbonated water with amino acids and chromium; Dietary supplement: Placebo Carbonated Water

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Dept Experimental Medical Science, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Carbonated water with amino acids and chromium; 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
Placebo Comparator: Carbonated water; 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; The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin	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 Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin	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 two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin	Blood samples will be collected at 7 time points during the 120 minutes.	0, 15, 30, 45, 60, 90 and 120 minutes post test meal
The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin	Blood samples will be collected at 5 time points during the 60 minutes.	0, 15, 30, 45 and 60 minutes post test meal
Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood.	A delta value will be calculated from samples collected at time=0 and time=60 minutes	0 and 60 minutes post test meal
Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood.	A delta value will be calculated from samples collected at time=0 and time=120 minutes	0 and 120 minutes post test meal

Collaborators and Investigators

• Sponsor: DoubleGood AB
• Collaborators: Lund University
• Investigators: Principal Investigator: Kristina E Andersson, PhD, Lund University and Aventure AB

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): September 5, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Diabetes Mellitus, Type 2; Metabolic Syndrome; Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium
• Other Study ID Numbers: DG1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No