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

Evaluating the Efficacy of I-fiber Pearl on Reducing Body Fat Accumulation in Obese Subjects: a Randomized, Double-blind, and Placebo-controlled Trial

The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: I-Fiber Pearl

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • South
    • Taichung, South, Taiwan, 402
      • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day.	Dietary supplement: placebo; Eat 200g for once, and once a day.
Experimental: I-Fiber Pearl; I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day.	Dietary supplement: I-Fiber Pearl; Eat 200g for once, and once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline body weight at week 12	Compared the difference of body weight between the week 12 and 0.	Week 0, Week 12
Change from baseline body fat at week 12	Compared the difference of body fat between the week 12 and 0.	Week 0, Week 12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: ITSWAY BIOTECH INC.
• Investigators: Study Chair: Chin-Lin Hsu, Ph.D., Chung Shan Medical University; Principal Investigator: Chin-Lin Hsu, Ph.D., Chung Shan Medical University; Principal Investigator: Shiuan-Chih Chen, Dr., Chung Shan Medical University; Principal Investigator: Hung-Hsuan Kuo, Master, Chung Shan Medical University; Principal Investigator: Chun-Tse Tsai, Master, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): September 18, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: CS2-23093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No