Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOolong tea containing L-arabinose and indigestible dextrin
DIETARY_SUPPLEMENTOolong tea (Placebo)
Sponsors
Unitika Ltd.
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal circumference | Every 4 weeks (Overall 20 weeks) |
| Visceral fat area by CT scan | Week 0, Week 12 |
| Serum lipid profile | Every 4 weeks (Overall 20 weeks) |
| Body fat mass | Every 4 weeks (Overall 20 weeks) |
| Fasting serum glucose and HbA1c levels | Every 4 weeks (Overall 20 weeks) |
| Frequency of bowel movement | 20 weeks |
| Serum adiponectin and leptin levels | Week 0, Week 12 |
Countries
Japan
Outcome results
None listed