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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: I-Fiber Pearl; Dietary Supplement: placebo

• 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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-12
• Primary Completion: 2024-09-18
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27

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

Arm && Interventions

Group	Intervention	Description
I-Fiber Pearl	I-Fiber Pearl	I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day.
placebo	placebo	Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, South, Taiwan