NCT01039662

Brief Summary

This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable healthy

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

December 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

December 24, 2009

Last Update Submit

June 22, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose level

    2 hours

Study Arms (2)

Oolong tea containing L-arabinose and indigestible dextrin

EXPERIMENTAL
Dietary Supplement: L-arabinose and indigestible dextrin

Oolong tea

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

L-arabinose and indigestible dextrinDIETARY_SUPPLEMENT
Oolong tea containing L-arabinose and indigestible dextrin
PlaceboDIETARY_SUPPLEMENT
Oolong tea

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy as based on medical history and physical examination
  • BMI is less or equal to 30 kg/m2
  • Willing not to serve as blood donor during the study
  • Informed consent signed

You may not qualify if:

  • Impaired Glucose Tolerance
  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 1 of this study
  • Renal or hepatic dysfunction
  • Heart disease
  • Under medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8551, Japan

Location

MeSH Terms

Interventions

Arabinose

Intervention Hierarchy (Ancestors)

PentosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 25, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

JP(1)