Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity
Not Applicable
Completed
- Conditions
- Obesity
- Registration Number
- NCT00880958
- Lead Sponsor
- Hiroshima University
- Brief Summary
The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
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
- Food allergy
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body mass index 16 weeks
- Secondary Outcome Measures
Name Time Method Body fat mass Week -4, Week 0, Week 4, Week 12 Abdominal circumference Week -4, Week 0, Week 4, Week 12 Visceral fat area by CT scan Week 0, Week 12 Intestinal flora Week 0, Week 12 Serum lipid profile Week -4, Week 0, Week 4, Week 12 Serum adiponectin and leptin levels Week 0, Week 12 Fasting serum glucose and HbA1c levels Week -4, Week 0, Week 4, Week 12
Trial Locations
- Locations (1)
Hiroshima University
🇯🇵Hiroshima, Japan
Hiroshima University🇯🇵Hiroshima, Japan