Overweight and Obesity
Conditions
Brief summary
The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.
Detailed description
This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.
Interventions
DIETARY_SUPPLEMENTI-Fiber Pearl
Eat 200g for once, and once a day.
DIETARY_SUPPLEMENTplacebo
Eat 200g for once, and once a day.
Sponsors
ITSWAY BIOTECH INC.
Chung Shan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* female * aged 20-50 years old * body mass index is greater than or equal to 27 kg/m2 * waist greater than or equal to 80 cm
Exclusion criteria
* Subjects diagnosed with cancer and on curative care. * Subjects diagnosed with heart disease and on curative care. * Subjects who use other drugs whose pharmacological effects may affect the experiment or may aggravate the effects of the drug. * Subjects with systemic infection requiring antibiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline body weight at week 12 | Week 0, Week 12 | Compared the difference of body weight between the week 12 and 0. |
| Change from baseline body fat at week 12 | Week 0, Week 12 | Compared the difference of body fat between the week 12 and 0. |
Countries
Taiwan
Outcome results
None listed