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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Placebo drink; Dietary Supplement: 5AA+CrPic Water

• Registration Number: NCT03411395
• Lead Sponsor: DoubleGood AB

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-13
• Primary Completion: 2016-12-20
• Study Completion: 2016-12-20
• Status Verified: 2018-01
• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-19
• Last Update Submitted: 2018-01-19
• Study First Posted: 2018-01-26
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo drink	Placebo drink	A standardized breakfast meal will be provided together with carbonated water containing aroma
5AA+CrPic Water Dose 2	5AA+CrPic Water	A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic
5AA+CrPic Water Dose 1	5AA+CrPic Water	A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic
5AA+CrPic Water Dose 3	5AA+CrPic Water	A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic

Primary Outcome Measures

Name	Time	Method
Blood glucose response	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 Outcome Measures

Name	Time	Method
Cmax of capillary blood glucose	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.
Serum insulin response	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.
Venous blood glucose response	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.
GLP-1 response	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.
Capillary blood glucose response	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.