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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo drink; Dietary supplement: 5AA+CrPic Water

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo drink; A standardized breakfast meal will be provided together with carbonated water containing aroma	Other: Placebo drink; Placebo water with carbonation and aroma
EXPERIMENTAL: 5AA+CrPic Water Dose 1; A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic	Dietary supplement: 5AA+CrPic Water; Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate; Other Names: Good Idea
EXPERIMENTAL: 5AA+CrPic Water Dose 2; A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic	Dietary supplement: 5AA+CrPic Water; Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate; Other Names: Good Idea
EXPERIMENTAL: 5AA+CrPic Water Dose 3; A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic	Dietary supplement: 5AA+CrPic Water; Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate; Other Names: Good Idea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose response	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.	3h postprandial phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of capillary blood glucose	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.	3h postprandial phase
Serum insulin response	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.	3h postprandial phase
Venous blood glucose response	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.	3h postprandial phase
GLP-1 response	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.	1h postprandial phase
Capillary blood glucose response	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.	2h postprandial phase

Collaborators and Investigators

• Sponsor: DoubleGood AB
• Collaborators: Lund University; Aventure AB
• Investigators: Principal Investigator: Elin Östman, PhD, Scheelevägen 22 223 63 Lund, Sweden; Study Director: Kristina Andersson, PhD, Experimental Medical Science, Lund University, Sweden; Study Chair: Lovisa Heyman-Lindén, PhD, Scheelevägen 22 223 63 Lund, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2016
• Primary Completion (ACTUAL): December 20, 2016
• Study Completion (ACTUAL): December 20, 2016

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (ACTUAL): January 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Prediabetes; Blood sugar regulation
• Other Study ID Numbers: DG1603Lund