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
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 April 16, 2014