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Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin

This study has been completed.
Sponsor:
Collaborator:
UNITIKA. Ltd.
Information provided by:
Hiroshima University
ClinicalTrials.gov Identifier:
NCT01039662
First received: December 24, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: L-arabinose and indigestible dextrin
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of the Combination of L-Arabinose and Indigestible Dextrin on Glycemic Index: a Double-Blind, Crossover Trial

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Postprandial glucose level [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oolong tea containing L-arabinose and indigestible dextrin Dietary Supplement: L-arabinose and indigestible dextrin
Placebo Comparator: Oolong tea Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039662

Locations
Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
UNITIKA. Ltd.
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT01039662     History of Changes
Other Study ID Numbers: eki-199
Study First Received: December 24, 2009
Last Updated: June 22, 2011
Health Authority: Japan: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013