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

NCT ID: NCT06203834

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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placebo

Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Eat 200g for once, and once a day.

I-Fiber Pearl

I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day.

Group Type EXPERIMENTAL

I-Fiber Pearl

Intervention Type DIETARY_SUPPLEMENT

Eat 200g for once, and once a day.

Interventions

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I-Fiber Pearl

Eat 200g for once, and once a day.

Intervention Type DIETARY_SUPPLEMENT

placebo

Eat 200g for once, and once a day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ITSWAY BIOTECH INC.

UNKNOWN

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin-Lin Hsu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Lin Hsu, Ph.D.

Role: STUDY_CHAIR

Chung Shan Medical University

Chin-Lin Hsu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Shiuan-Chih Chen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Hung-Hsuan Kuo, Master

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Chun-Tse Tsai, Master

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS2-23093

Identifier Type: -

Identifier Source: org_study_id