Clinical trial NCT03411395: Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Diabetes
Prediabetes
Blood sugar regulation
Lead sponsor: DoubleGood AB
Sponsor class: INDUSTRY
Collaborators: name: Lund University
name: Aventure AB
First posted: 2018-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Blood glucose response
timeFrame: 3h postprandial phase
Secondary outcomes:
measure: Cmax of capillary blood glucose
timeFrame: 3h postprandial phase
measure: Serum insulin response
timeFrame: 3h postprandial phase
measure: Venous blood glucose response
timeFrame: 3h postprandial phase
measure: GLP-1 response
timeFrame: 1h postprandial phase
measure: Capillary blood glucose response
timeFrame: 2h postprandial phase
Other outcomes:
Locations:
Study officials:
affiliation: Scheelevägen 22 223 63 Lund, Sweden
name: Elin Östman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Experimental Medical Science, Lund University, Sweden
name: Kristina Andersson, PhD
role: STUDY_DIRECTOR
affiliation: Scheelevägen 22 223 63 Lund, Sweden
name: Lovisa Heyman-Lindén, PhD
role: STUDY_CHAIR
References: