- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801540
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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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