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

Sponsor
DoubleGood AB (Industry)
Overall Status
Completed
CT.gov ID
NCT02487680
Collaborator
Lund University (Other)
20
Enrollment
2
Arms
5
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Amino Acids and chromium-picolinate containing drink
  • Dietary Supplement: Placebo drink
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of a Table Water Enriched With Amino Acids and Chromium on Blood Glucose and Insulin Levels After a Meal
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breakfast meal

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

Dietary Supplement: Amino Acids and chromium-picolinate containing drink
Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Dietary Supplement: Placebo drink
Evaluation of the placebo supplement drink containing only aroma
Experimental: Lunch meal

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

Dietary Supplement: Amino Acids and chromium-picolinate containing drink
Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma

Dietary Supplement: Placebo drink
Evaluation of the placebo supplement drink containing only aroma

Outcome Measures

Primary Outcome Measures

  1. Area under the curve for Glucose after ingestion of a test meal [180 min]

Secondary Outcome Measures

  1. Area under the curve for insulin after ingestion of a test meal [180 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • DoubleGood AB
  • Lund University

Investigators

  • Principal Investigator: Per Humpert, MD, Prof, Stoffwechselzentrum Rhein Pfalts, Mannheim, Germany and Department of internal medicine, University of Heidelberg, Germany
  • Study Director: Ana Rascón, PhD, Prof, Food for Health Science Center, Lund University, Sweden
  • Study Chair: Kristina Andersson, PhD, Experimental Medical Science, Lund University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DoubleGood AB
ClinicalTrials.gov Identifier:
NCT02487680
Other Study ID Numbers:
  • DoubleGood Lund
First Posted:
Jul 1, 2015
Last Update Posted:
May 12, 2017
Last Verified:
May 1, 2017
Additional relevant MeSH terms:
Chromium
Picolinic acid

Study Results

No Results Posted as of May 12, 2017