NCT00880646CompletedNot Applicable
Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity: a Double-Blind, Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hiroshima University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Body mass index
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Intervention: Oolong tea containing L-arabinose and indigestible dextrin (Dietary Supplement)
2
Placebo Comparator
Intervention: Oolong tea (Placebo) (Dietary Supplement)
Outcomes
Primary Outcomes
Body mass index
Time Frame: 20 weeks
Secondary Outcomes
- Body fat mass(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin and leptin levels(Week 0, Week 12)
- Abdominal circumference(Every 4 weeks (Overall 20 weeks))
- Visceral fat area by CT scan(Week 0, Week 12)
- Frequency of bowel movement(20 weeks)
- Serum lipid profile(Every 4 weeks (Overall 20 weeks))
- Fasting serum glucose and HbA1c levels(Every 4 weeks (Overall 20 weeks))
Investigators
Study Sites (1)
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