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The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man (M192)

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo comparator: 0% pentose
Active comparator: 4% D-xylose
Active comparator: 8% D-xylose
Active comparator: 8% L-arabinose
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring L-arabinose, D-xylose, sucrose, glucose, insulin, C-peptide, GLP-1

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Human Nutrition, The Royal Veterinary and Agricultural University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

0% pentose

4% D-xylose

8% D-xylose

8% L-arabinose

Arm Description

Pure sucrose without pentoses added.

Sucrose drink supplemented with 4% D-xylose

Sucrose drink supplemented with 8% D-xylose

Sucrose drink supplemented with 8% L-arabinose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2013
Last Updated
October 7, 2013
Sponsor
University of Copenhagen
Collaborators
Danisco
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1. Study Identification

Unique Protocol Identification Number
NCT01957098
Brief Title
The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
Acronym
M192
Official Title
The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Danisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
L-arabinose, D-xylose, sucrose, glucose, insulin, C-peptide, GLP-1

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0% pentose
Arm Type
Placebo Comparator
Arm Description
Pure sucrose without pentoses added.
Arm Title
4% D-xylose
Arm Type
Active Comparator
Arm Description
Sucrose drink supplemented with 4% D-xylose
Arm Title
8% D-xylose
Arm Type
Active Comparator
Arm Description
Sucrose drink supplemented with 8% D-xylose
Arm Title
8% L-arabinose
Arm Type
Active Comparator
Arm Description
Sucrose drink supplemented with 8% L-arabinose
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo comparator: 0% pentose
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Active comparator: 4% D-xylose
Intervention Type
Dietary Supplement
Intervention Name(s)
Active comparator: 8% D-xylose
Intervention Type
Dietary Supplement
Intervention Name(s)
Active comparator: 8% L-arabinose
Primary Outcome Measure Information:
Title
Blood glucose, insulin, C-peptide and GLP-1
Description
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
Time Frame
-15, 0, 15, 30, 45, 60, 90, 120, 180 min
Secondary Outcome Measure Information:
Title
Appetite measurements and energy intake
Description
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.
Time Frame
-15, 30, 60, 90, 120, 150 and 180 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD,MPA
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Human Nutrition, The Royal Veterinary and Agricultural University
City
Frederiksberg
ZIP/Postal Code
DK-1958
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

The Effects of L-Arabinose and D-xylose on Intestinal Sucrase Activity in Man

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