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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01039662
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Unitika Ltd.
Information provided by:
Hiroshima University

Tracking Information
First Submitted Date  ICMJE December 24, 2009
First Posted Date  ICMJE December 25, 2009
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2009)
Postprandial glucose level [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01039662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin
Official Title  ICMJE Effects of the Combination of L-Arabinose and Indigestible Dextrin on Glycemic Index: a Double-Blind, Crossover Trial
Brief Summary This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: L-arabinose and indigestible dextrin
  • Dietary Supplement: Placebo
Study Arms
  • Experimental: Oolong tea containing L-arabinose and indigestible dextrin
    Intervention: Dietary Supplement: L-arabinose and indigestible dextrin
  • Placebo Comparator: Oolong tea
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2011)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 24, 2009)
20
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01039662
Other Study ID Numbers  ICMJE eki-199
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fumiko Higashikawa, Associate professor, Hiroshima University
Study Sponsor  ICMJE Hiroshima University
Collaborators  ICMJE Unitika Ltd.
Investigators  ICMJE Not Provided
PRS Account Hiroshima University
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP