Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism on Healthy Subjects

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Dietary Supplement: Amino Acids and chromium-picolinate containing drink; Dietary Supplement: Placebo drink

• Registration Number: NCT02487680
• Lead Sponsor: DoubleGood AB

Brief Summary

It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Stable body weight (no changes above 3 kg during the last 2 months)
• Good general health
• Body mass index 19 - 30 kg/m2 (normal to overweight)
• Fasting blood glucose below 6.1 mmol/L

Exclusion Criteria

• Any medication that could influence the study. Such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia
• Psychiatric Disease
• Alcohol or drug abuse
• Smokers or people consuming snus
• Acute infections
• Vegetarians/vegans
• Suffering from Lactose or Gluten intolerance
• Pregnancy or Lactation
• Participation in another study at the same time
• Any other parameter that the PI will judge as inadequate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breakfast meal	Amino Acids and chromium-picolinate containing drink	A breakfast like meal will be provided together with a drink to overnight fasted subjects
Lunch meal	Placebo drink	A lunch like meal will be provided together with a drink to overnight fasted subjects
Breakfast meal	Placebo drink	A breakfast like meal will be provided together with a drink to overnight fasted subjects
Lunch meal	Amino Acids and chromium-picolinate containing drink	A lunch like meal will be provided together with a drink to overnight fasted subjects

Primary Outcome Measures

Name	Time	Method
Area under the curve for Glucose after ingestion of a test meal	180 min

Secondary Outcome Measures

Name	Time	Method
Area under the curve for insulin after ingestion of a test meal	180 min