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Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects

Not Applicable
Completed
Conditions
Overweight and Obesity
Registration Number
NCT06203834
Lead Sponsor
Chung Shan Medical University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline body weight at week 12Week 0, Week 12

Compared the difference of body weight between the week 12 and 0.

Change from baseline body fat at week 12Week 0, Week 12

Compared the difference of body fat between the week 12 and 0.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Chung Shan Medical University

🇨🇳

Taichung, South, Taiwan

Chung Shan Medical University
🇨🇳Taichung, South, Taiwan

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