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

Information source: DoubleGood AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: Amino Acids and chromium-picolinate containing drink (Dietary Supplement); Placebo drink (Dietary Supplement)

Phase: N/A

Status: Active, not recruiting

Sponsored by: DoubleGood AB

Official(s) and/or principal investigator(s):
Per Humpert, MD, Prof, Principal Investigator, Affiliation: Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany
Ana Rascón, PhD, Prof, Study Director, Affiliation: Food for Health Science Center, Lund University, Sweden
Kristina Andersson, PhD, Study Chair, Affiliation: Experimental Medical Science, Lund University, Sweden

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.

Clinical Details

Official title: Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Area under the curve for Glucose after ingestion of a test meal

Secondary outcome: Area under the curve for insulin after ingestion of a test meal

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: June 2015
Last updated: July 1, 2015

Page last updated: August 23, 2015

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