- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957098
The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man (M192)
October 7, 2013 updated by: AAstrup, University of Copenhagen
The purpose of this study is to investigate the effect of L-arabinose and D-xylose in a sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose and D-xylose.
Study Overview
Status
Completed
Conditions
Detailed Description
Based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Frederiksberg, Denmark, DK-1958
- Institute of Human Nutrition, The Royal Veterinary and Agricultural University
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-
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 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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 0% pentose
Pure sucrose without pentoses added.
|
14 healthy subjects participated in a randomized double-blinded cross-over study based on four single tests.
Sucrose containing drinks were supplemented with two different doses of D-xylose and in addition one dose of L-arabinose was included for comparison with earlier studies.
Blood was collected fasting and for 3-h postprandially.
Appetite sensations and energy intake were registered.
Gastrointestinal symptoms were monitored for 24 hours
|
|
Active Comparator: 4% D-xylose
Sucrose drink supplemented with 4% D-xylose
|
|
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Active Comparator: 8% D-xylose
Sucrose drink supplemented with 8% D-xylose
|
|
|
Active Comparator: 8% L-arabinose
Sucrose drink supplemented with 8% L-arabinose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose, insulin, C-peptide and GLP-1
Time Frame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
|
Level of glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) over time, the area under the curve (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 |
|---|---|---|
|
Appetite measurements and energy intake
Time Frame: -15, 30, 60, 90, 120, 150 and 180 min
|
Appetite measurements: area under/over the curve (AUC/AOC), 3-h mean.
Energy intake: the ad libitum energy intake at lunch was registered.
VAS was used to asses the palatability (appearance, smell, taste, after-taste and overall palatability) of the ad libitum lunch.
|
-15, 30, 60, 90, 120, 150 and 180 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Jens R Andersen, MD,MPA, Department of Nutrition, Exercise and sports, University of Copenhagen
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
October 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
August 8, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Estimate)
October 8, 2013
Last Update Submitted That Met QC Criteria
October 7, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (KF) 11 324909
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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