NCT01957098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

August 8, 2013

Last Update Submit

October 7, 2013

Conditions

Keywords

L-arabinoseD-xylosesucroseglucoseinsulinC-peptideGLP-1

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Appetite measurements and energy intake

    -15, 30, 60, 90, 120, 150 and 180 min

Study Arms (4)

0% pentose

PLACEBO COMPARATOR

Pure sucrose without pentoses added.

Dietary Supplement: Placebo comparator: 0% pentose

4% D-xylose

ACTIVE COMPARATOR

Sucrose drink supplemented with 4% D-xylose

Dietary Supplement: Active comparator: 4% D-xylose

8% D-xylose

ACTIVE COMPARATOR

Sucrose drink supplemented with 8% D-xylose

Dietary Supplement: Active comparator: 8% D-xylose

8% L-arabinose

ACTIVE COMPARATOR

Sucrose drink supplemented with 8% L-arabinose

Dietary Supplement: Active comparator: 8% L-arabinose

Interventions

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

0% pentose
4% D-xylose
8% D-xylose
8% L-arabinose

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males
  • BMI between 18.4-25 kg/m2
  • age between 18 and 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, DK-1958, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

PentosesXyloseArabinose

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MonosaccharidesSugarsCarbohydrates

Study Officials

  • Jens R Andersen, MD,MPA

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

October 8, 2013

Study Start

October 1, 2006

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations