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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01957098
Other study ID # (KF) 11 324909
Secondary ID
Status Completed
Phase N/A
First received August 8, 2013
Last updated October 7, 2013
Start date October 2006
Est. completion date May 2007

Study information

Verified date October 2013
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

Based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo comparator: 0% pentose
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

Active comparator: 8% D-xylose

Active comparator: 8% L-arabinose


Locations

Country Name City State
Denmark Institute of Human Nutrition, The Royal Veterinary and Agricultural University Frederiksberg

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Danisco

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose, insulin, C-peptide and GLP-1 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 No
Secondary Appetite measurements and energy intake 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 No
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