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

DoubleGood

Status: Completed

Conditions: Healthy

Treatments: Other: Placebo drink; Dietary Supplement: 5AA+CrPic Water

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03411395

DG1603Lund

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 4 patient groups, including a placebo group

Placebo drink

Placebo Comparator group

Description:

A standardized breakfast meal will be provided together with carbonated water containing aroma

Treatment:

Other: Placebo drink

5AA+CrPic Water Dose 1

Experimental group

Description:

A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic

Treatment:

Dietary Supplement: 5AA+CrPic Water

5AA+CrPic Water Dose 2

Experimental group

Description:

A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic

Treatment:

Dietary Supplement: 5AA+CrPic Water

5AA+CrPic Water Dose 3

Experimental group

Description:

A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic

Treatment:

Dietary Supplement: 5AA+CrPic Water