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

NCT ID: NCT03411395

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-13
• Study Completion Date: 2016-12-20

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo drink

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

Group Type: PLACEBO_COMPARATOR

Placebo drink

Intervention Type: OTHER

Placebo water with carbonation and aroma

5AA+CrPic Water Dose 1

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

Group Type: EXPERIMENTAL

5AA+CrPic Water

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

5AA+CrPic Water

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

5AA+CrPic Water

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

5AA+CrPic Water

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo drink

Placebo water with carbonation and aroma

Intervention Type: OTHER

Other Intervention Names

Good Idea

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Aventure AB

INDUSTRY

Sponsor Role: collaborator

DoubleGood AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elin Östman, PhD

Role: PRINCIPAL_INVESTIGATOR

Scheelevägen 22 223 63 Lund, Sweden

Kristina Andersson, PhD

Role: STUDY_DIRECTOR

Experimental Medical Science, Lund University, Sweden

Lovisa Heyman-Lindén, PhD

Role: STUDY_CHAIR

Scheelevägen 22 223 63 Lund, Sweden

Other Identifiers

DG1603Lund

Identifier Type: -

Identifier Source: org_study_id