Skip to main content
OpenTrials
Completed

NCT Number: NCT03552315

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postprandial Hyperglycemia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Experimental Medical Science, Lund University

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbonated water with amino acids and chromium

Dietary Supplement

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 Carbonated Water

Dietary Supplement

The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes

Primary outcomes

  1. The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes

    Time frame: 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.

Secondary outcomes

  1. The three-hour iAUC for insulin, 0-180 minutes

    Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

    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.

  2. The three hour iAUC for intravenous glucose, 0-180 minutes

    Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

    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.

  3. The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes

    Time frame: 0, 15, 30, 45 and 60 minutes post test meal

    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.

Other outcomes

  1. The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin

    Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

    Blood samples will be collected at 8 time points during the 180 minutes.

  2. The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin

    Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal

    Blood samples will be collected at 8 time points during the 180 minutes.

  3. The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin

    Time frame: 0, 15, 30, 45, 60, 90 and 120 minutes post test meal

    Blood samples will be collected at 7 time points during the 120 minutes.

  4. The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin

    Time frame: 0, 15, 30, 45 and 60 minutes post test meal

    Blood samples will be collected at 5 time points during the 60 minutes.

  5. Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood.

    Time frame: 0 and 60 minutes post test meal

    A delta value will be calculated from samples collected at time=0 and time=60 minutes

  6. Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood.

    Time frame: 0 and 120 minutes post test meal

    A delta value will be calculated from samples collected at time=0 and time=120 minutes

Sponsors and collaborators

Lead sponsor

DoubleGood AB

Industry

Collaborators

  • Lund University

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.