Preventive Effect of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults

January 3, 2024 updated by: Chin-Lin Hsu, Chung Shan Medical University
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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • South
      • Taichung, South, Taiwan, 402
        • Recruiting
        • Chung Shan Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Week 0, 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
Time Frame: Week 0, Week 12
Compared the difference of body fat between the week 12 and 0.
Week 0, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Collaborators

ITSWAY BIOTECH INC.

Investigators

  • Principal Investigator: Hung-Hsuan KUO, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 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)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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