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

Primary Purpose

Postprandial Hyperglycemia, Metabolic Syndrome, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Carbonated water with amino acids and chromium
Placebo Carbonated Water
Sponsored by
DoubleGood AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept Experimental Medical Science, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Water with amino acids and chromium

Carbonated water

Arm Description

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.

The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 23, 2018
Last Updated
September 2, 2019
Sponsor
DoubleGood AB
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03552315
Brief Title
Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DoubleGood AB
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia, Metabolic Syndrome, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water with amino acids and chromium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Carbonated water
Arm Type
Placebo Comparator
Arm Description
The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbonated water with amino acids and chromium
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Carbonated Water
Intervention Description
The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
Primary Outcome Measure Information:
Title
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
Description
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.
Time Frame
0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Secondary Outcome Measure Information:
Title
The three-hour iAUC for insulin, 0-180 minutes
Description
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.
Time Frame
0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Title
The three hour iAUC for intravenous glucose, 0-180 minutes
Description
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.
Time Frame
0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Title
The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes
Description
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.
Time Frame
0, 15, 30, 45 and 60 minutes post test meal
Other Pre-specified Outcome Measures:
Title
The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin
Description
Blood samples will be collected at 8 time points during the 180 minutes.
Time Frame
0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Title
The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin
Description
Blood samples will be collected at 8 time points during the 180 minutes.
Time Frame
0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
Title
The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
Description
Blood samples will be collected at 7 time points during the 120 minutes.
Time Frame
0, 15, 30, 45, 60, 90 and 120 minutes post test meal
Title
The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
Description
Blood samples will be collected at 5 time points during the 60 minutes.
Time Frame
0, 15, 30, 45 and 60 minutes post test meal
Title
Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood.
Description
A delta value will be calculated from samples collected at time=0 and time=60 minutes
Time Frame
0 and 60 minutes post test meal
Title
Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood.
Description
A delta value will be calculated from samples collected at time=0 and time=120 minutes
Time Frame
0 and 120 minutes post test meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina E Andersson, PhD
Organizational Affiliation
Lund University and Aventure AB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Experimental Medical Science, Lund University
City
Lund
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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