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
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