Status:

COMPLETED

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

Lead Sponsor:

DoubleGood AB

Collaborating Sponsors:

Lund University

Aventure AB

Conditions:

Healthy

Eligibility:

All Genders

20-60 years

Phase:

NA

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 13 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2016

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT03411395

Start Date

October 13 2016

End Date

December 20 2016

Last Update

January 26 2018

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