The Effects of L-arabinose in a Meal in Healthy Men

February 27, 2013 updated by: AAstrup, University of Copenhagen

The Effects of L-arabinose in a Meal on Glucose Metabolism in Healthy Men

The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.

Study Overview

Study Type

Interventional

Enrollment (Actual)

17

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 to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male
  • normal weight (BMI 18,5-25 kg/m2)
  • 18-30 years of age

Exclusion Criteria:

  • Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders
  • Central adipositas (defined as waist circumference > 94 cm for european men)
  • Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.
  • elevated alcoholcunsumption(> 21 units af alcohol pr. week)
  • take medicine
  • Elite athlete with intensive training
  • given bloddonation within the last 3 months
  • smoking

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0% arabinose meal sucrose/starch
A meal containing a bon with butter and marmalade, a cup cake, The and water
L-arabinose is mixed into the dough of the buns and cup cakes
OTHER: 5 % arabinose meal sucrose/starch
A meal containing a bon with butter and marmalade, a cup cake, The and water
L-arabinose is mixed into the dough of the buns and cup cakes
OTHER: 10 % arabinose meal sucrose/starch
A meal containing a bon with butter and marmalade, a cup cake, The and water
L-arabinose is mixed into the dough of the buns and cup cakes
OTHER: 0 % arabinose meal Starch
A meal containing two bons with butter and cheese, The and water
L-arabinose is mixed into the dough of the buns and cup cakes
OTHER: 5 % arabinose meal starch
A meal containing two bons with butter and cheese, The and water
L-arabinose is mixed into the dough of the buns and cup cakes
OTHER: 10 % arabinose meal starch
A meal containing two bons with butter and cheese, The and water
L-arabinose is mixed into the dough of the buns and cup cakes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of glucose over time, The AUC, the peak value and time to peak
-15, 0, 15, 30, 45, 60, 90, 120, 180 min
Insulin
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of insulin over time, the AUC, the peak value and time to peak
-15, 0, 15, 30, 45, 60, 90, 120, 180 min
C-peptide
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of c-peptide over time, The AUC, the peak value and time to peak
-15, 0, 15, 30, 45, 60, 90, 120, 180 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of glucagon over time, The AUC, the peak value and time to peak
-15, 0, 15, 30, 45, 60, 90, 120, 180 min
GLP-1
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Level of GLP-1 over time, The AUC, the peak value and time to peak
-15, 0, 15, 30, 45, 60, 90, 120, 180 min

Collaborators and Investigators

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

Investigators

  • Study Director: Jens Rikardt Andersen, MD, lector, Unit of Nutrition 5711, Rigshospitalet, Blegdamsvej 9, 2100 København Ø

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

December 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (ESTIMATE)

February 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • H-2-2010-095

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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