Overview

This trial is active, not recruiting.

Condition diabetes
Treatments amino acids and chromium-picolinate containing drink, placebo drink
Sponsor DoubleGood AB
Collaborator Lund University
Start date June 2015
End date September 2015
Trial size 20 participants
Trial identifier NCT02487680, DoubleGood Lund

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
A breakfast like meal will be provided together with a drink to overnight fasted subjects
amino acids and chromium-picolinate containing drink
Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma
placebo drink
Evaluation of the placebo supplement drink containing only aroma
(Experimental)
A lunch like meal will be provided together with a drink to overnight fasted subjects
amino acids and chromium-picolinate containing drink
Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma
placebo drink
Evaluation of the placebo supplement drink containing only aroma

Primary Outcomes

Measure
Area under the curve for Glucose after ingestion of a test meal
time frame: 180 min

Secondary Outcomes

Measure
AUC for insulin after ingestion of a test meal
time frame: 180 min

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Vegerarians/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

Additional Information

Official title Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal
Principal investigator Per Humpert, MD, Prof
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by DoubleGood AB.