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

NCT03411395 | Completed

• 1 other identifier: DG1603Lund
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Keywords

Diabetes; Prediabetes; Blood sugar regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax of capillary blood glucose

  3h postprandial phase

• Serum insulin response

  3h postprandial phase

• Venous blood glucose response

  3h postprandial phase

• GLP-1 response

  1h postprandial phase

• Capillary blood glucose response

  2h postprandial phase

Study Arms (4)

Placebo drink

PLACEBO COMPARATOR

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

Other: Placebo drink

5AA+CrPic Water Dose 1

EXPERIMENTAL

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

Dietary Supplement: 5AA+CrPic Water

5AA+CrPic Water Dose 2

EXPERIMENTAL

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

5AA+CrPic Water Dose 3

EXPERIMENTAL

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

Interventions

5AA+CrPic Water DIETARY_SUPPLEMENT

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

Also known as: Good Idea

5AA+CrPic Water Dose 1; 5AA+CrPic Water Dose 2; 5AA+CrPic Water Dose 3

Placebo drink OTHER

Placebo water with carbonation and aroma

Placebo drink

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DoubleGood AB: lead
• Lund University: collaborator
• Aventure AB: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elin Östman, PhD

  Scheelevägen 22 223 63 Lund, Sweden

  PRINCIPAL INVESTIGATOR

• Kristina Andersson, PhD

  Experimental Medical Science, Lund University, Sweden

  STUDY DIRECTOR

• Lovisa Heyman-Lindén, PhD

  Scheelevägen 22 223 63 Lund, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 26, 2018
• Study Start: October 13, 2016
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: January 26, 2018

Record last verified: 2018-01