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

May 11, 2017 updated by: DoubleGood AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve for Glucose after ingestion of a test meal
Time Frame: 180 min
180 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve for insulin after ingestion of a test meal
Time Frame: 180 min
180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DoubleGood AB

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DoubleGood Lund

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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