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Completed

NCT Number: NCT03411395

Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.

It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.

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Key information

Conditions

Healthy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index 18-25 (±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

  • Pregnancy or lactation
  • Known Type I or Type II diabetes
  • Undetected Type I or Type II diabetes (fasting blood glucose < 6.1 mmol/L at first test day)
  • Use of antibiotics
  • Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
  • Allergy to test product or placebo ingredients
  • Participants restricted to a vegetarian or vegan diet
  • Intolerance to lactose or gluten
  • Acute infection
  • Individuals who are averse to venous catheterization or capillary blood sampling
  • Alcohol or drug abuse
  • Currently active smokers (tobacco products, and e-cigarettes)
  • Participation in other clinical research trials
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the PI'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
  • Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the PI
  • 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 PI. 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.

Treatment and study plan

5AA+CrPic Water

Dietary Supplement

Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate

Other names: Good Idea

Placebo drink

Other

Placebo water with carbonation and aroma

Primary outcomes

  1. Blood glucose response

    Time frame: 3h postprandial phase

    The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal.

Secondary outcomes

  1. Cmax of capillary blood glucose

    Time frame: 3h postprandial phase

    The difference in the three-hour Cmax (0 - 180 min) of capillary blood glucose between 5AA+CrPic test products and the placebo following a standardized meal.

  2. Serum insulin response

    Time frame: 3h postprandial phase

    The difference of the three-hour iAUC (0 - 180 min) intravenous serum insulin iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  3. Venous blood glucose response

    Time frame: 3h postprandial phase

    The difference of the three-hour iAUC (0 - 180 min) intravenous plasma glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  4. GLP-1 response

    Time frame: 1h postprandial phase

    The difference of the 1h iAUC (0 - 60 min) intravenous blood glucagon-like peptide 1 (GLP-1) iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

  5. Capillary blood glucose response

    Time frame: 2h postprandial phase

    The difference in the two-hour iAUC (0 - 120 min) capillary blood glucose iAUC between 5AA+CrPic test products and the placebo following a standardized meal.

Sponsors and collaborators

Lead sponsor

DoubleGood AB

Industry

Collaborators

  • Aventure AB
  • Lund University

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2018
Registry last updated
Jan 26, 2018

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.

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