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

This study has been completed.
Sponsor:
Collaborator:
UNITIKA. Ltd.
Information provided by:
Hiroshima University
ClinicalTrials.gov Identifier:
NCT00880646
First received: April 13, 2009
Last updated: October 28, 2009
Last verified: October 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body fat mass [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Abdominal circumference [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Visceral fat area by CT scan [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Serum lipid profile [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Serum adiponectin and leptin levels [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
  • Fasting serum glucose and HbA1c levels [ Time Frame: Every 4 weeks (Overall 20 weeks) ] [ Designated as safety issue: No ]
  • Frequency of bowel movement [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880646

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

No publications provided

Responsible Party: Fumiko Higashikawa, PhD/Associate professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT00880646     History of Changes
Other Study ID Numbers: eki-124
Study First Received: April 13, 2009
Last Updated: October 28, 2009
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014