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

NCT ID: NCT02487680

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Breakfast meal

A breakfast like meal will be provided together with a drink to overnight fasted subjects

Group Type: EXPERIMENTAL

Amino Acids and chromium-picolinate containing drink

Intervention Type: DIETARY_SUPPLEMENT

Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Placebo drink

Intervention Type: DIETARY_SUPPLEMENT

Evaluation of the placebo supplement drink containing only aroma

Lunch meal

A lunch like meal will be provided together with a drink to overnight fasted subjects

Group Type: EXPERIMENTAL

Amino Acids and chromium-picolinate containing drink

Intervention Type: DIETARY_SUPPLEMENT

Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Placebo drink

Intervention Type: DIETARY_SUPPLEMENT

Evaluation of the placebo supplement drink containing only aroma

Interventions

Amino Acids and chromium-picolinate containing drink

Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Intervention Type: DIETARY_SUPPLEMENT

Placebo drink

Evaluation of the placebo supplement drink containing only aroma

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

DoubleGood AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Humpert, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany

Ana Rascón, PhD, Prof

Role: STUDY_DIRECTOR

Food for Health Science Center, Lund University, Sweden

Kristina Andersson, PhD

Role: STUDY_CHAIR

Experimental Medical Science, Lund University, Sweden

Other Identifiers

DoubleGood Lund

Identifier Type: -

Identifier Source: org_study_id