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NCT Number: NCT02487680

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino Acids and chromium-picolinate containing drink

Dietary Supplement

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

Placebo drink

Dietary Supplement

Evaluation of the placebo supplement drink containing only aroma

Primary outcomes

  1. Area under the curve for Glucose after ingestion of a test meal

    Time frame: 180 min

Secondary outcomes

  1. Area under the curve for insulin after ingestion of a test meal

    Time frame: 180 min

Sponsors and collaborators

Lead sponsor

DoubleGood AB

Industry

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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