- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00302302
The Effects of L-arabinose on Intestinal Sucrase Activity in Man
The Effects of Increasing Doses of L-arabinose in a Sucrose Rich Meal on Intestinal Sucrase Activity in Man
Study Overview
Detailed Description
Background:
The intake of common table sugar (sucrose) in the industrialised countries is relatively high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake of sugar containing drinks. The health consequences of this relatively high sugar intake are heavily debated in the media. One of the arguments is that a high sugar intake may be one of the factors involved in the development of the metabolic syndrome, including overweight, increased blood glucose and insulin levels as well as impaired insulin action.
L-arabinose is widely distributed in plants and is a common component in plant cell walls in maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose is a potent inhibitor on sucrase activity, possibly in a non-competitive way.
Potential nutritional advantages of consuming L-arabinose in combination with sucrose may therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the energy utilisation with the potential of reducing weight gain in human subjects.
Methods:
This dose-response study with 14 healthy male volunteers has a randomised cross-over design based on four single "meals" separated by one week wash-out periods. Sugar rich drinks supplemented with different doses of L-arabinose will be tested with respect to postprandial blood glucose, insulin, triglyceride, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1). Postprandial blood samples will be taken every 15 to 30 min for 180 min. Appetite sensations will be measured every 30 min during the experiment. After 180 minutes a lunch will be served and energy intake (EI) will be registered.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Frederiksberg, Denmark, DK-1958
- Institute of Human Nutrition, The Royal Veterinary and Agricultural University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy males
- BMI between 18.4-25 kg/m2
- age between 18 and 30
Exclusion Criteria:
- donation of blood 3 months before or during the study
- gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (HIV or hepatitis)
- smoking
- consumption of more than 21 alcoholic drinks/week
- elite athletes
- on medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose, insulin, triglycerides, GIP and GLP-1
Time Frame: 2 hours
|
Blood samples 2 hours after a test meal
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite measurements and energy intake
Time Frame: 10 hours
|
measured after a test meal
|
10 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Klaus Bukhave, MSc, MScD, Institute of Human Nutrition, THe Royal Veterinary and Agricultural University, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- (KF) 01 270121
- M181
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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