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

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ClinicalTrials.gov Identifier: NCT02487680
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
DoubleGood AB

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
Diabetes Dietary Supplement: Amino Acids and chromium-picolinate containing drink Dietary Supplement: Placebo drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Area under the curve for Glucose after ingestion of a test meal [ Time Frame: 180 min ]

Secondary Outcome Measures :
  1. Area under the curve for insulin after ingestion of a test meal [ Time Frame: 180 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487680


Sponsors and Collaborators
DoubleGood AB
Lund University
Investigators
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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

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Responsible Party: DoubleGood AB
ClinicalTrials.gov Identifier: NCT02487680     History of Changes
Other Study ID Numbers: DoubleGood Lund
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Chromium
Picolinic acid
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action