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Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880646
First Posted: April 14, 2009
Last Update Posted: October 29, 2009
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.
Collaborator:
Unitika Ltd.
Information provided by:
Hiroshima University
  Purpose
This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat mass, and serum biochemical parameters in overweight subjects.

Condition Intervention
Obesity Dietary Supplement: Oolong tea containing L-arabinose and indigestible dextrin Dietary Supplement: Oolong tea (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity: a Double-Blind, Randomized Controlled Trial

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Body fat mass [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  • Abdominal circumference [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  • Visceral fat area by CT scan [ Time Frame: Week 0, Week 12 ]
  • Serum lipid profile [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  • Serum adiponectin and leptin levels [ Time Frame: Week 0, Week 12 ]
  • Fasting serum glucose and HbA1c levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ]
  • Frequency of bowel movement [ Time Frame: 20 weeks ]

Estimated Enrollment: 70
Study Start Date: March 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Oolong tea containing L-arabinose and indigestible dextrin
Placebo Comparator: 2 Dietary Supplement: Oolong tea (Placebo)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as based on medical history and physical examination
  • BMI between 25 and 30 kg/m2
  • Willing not to serve as blood donor during the study
  • Informed consent signed

Exclusion Criteria:

  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 01 of this study
  • Renal or hepatic dysfunction
  • Heart disease
  • Under medication
  • Subjects who are taking functional food designed for weight loss or serum lipid reduction
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880646


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

Responsible Party: Fumiko Higashikawa, PhD/Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT00880646     History of Changes
Other Study ID Numbers: eki-124
First Submitted: April 13, 2009
First Posted: April 14, 2009
Last Update Posted: October 29, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms