NCT00302302

Brief Summary

The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

September 21, 2005

Last Update Submit

February 25, 2014

Conditions

Blood Glucose

Keywords

Blood glucoseInsulinTriglycerideGIPGLP-1L-arabinoseAppetiteEnergy intake

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose, insulin, triglycerides, GIP and GLP-1

    Blood samples 2 hours after a test meal

    2 hours

Secondary Outcomes (1)

  • Appetite measurements and energy intake

    10 hours

Interventions

L-arabinoseDRUG

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

Related Publications (1)

  • Krog-Mikkelsen I, Hels O, Tetens I, Holst JJ, Andersen JR, Bukhave K. The effects of L-arabinose on intestinal sucrase activity: dose-response studies in vitro and in humans. Am J Clin Nutr. 2011 Aug;94(2):472-8. doi: 10.3945/ajcn.111.014225. Epub 2011 Jun 15.

    PMID: 21677059DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Arabinose

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PentosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Klaus Bukhave, MSc, MScD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2005

First Posted

March 14, 2006

Study Start

September 1, 2005

Primary Completion

November 1, 2005

Study Completion

January 1, 2006

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations

DK(1)