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

Obesity Clinical Trial

Official title:

Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity: a Double-Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880646
• Other study ID #: eki-124
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: October 28, 2009
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Oolong tea containing L-arabinose and indigestible dextrin

• Oolong tea (Placebo)

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	Unitika Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		20 weeks	No
Secondary	Body fat mass		Every 4 weeks (Overall 20 weeks)	No
Secondary	Abdominal circumference		Every 4 weeks (Overall 20 weeks)	No
Secondary	Visceral fat area by CT scan		Week 0, Week 12	No
Secondary	Serum lipid profile		Every 4 weeks (Overall 20 weeks)	No
Secondary	Serum adiponectin and leptin levels		Week 0, Week 12	No
Secondary	Fasting serum glucose and HbA1c levels		Every 4 weeks (Overall 20 weeks)	No
Secondary	Frequency of bowel movement		20 weeks	No