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

Chung Shan Medical University

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: I-Fiber Pearl; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06203834

CS2-23093

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo

I-Fiber Pearl

Experimental group

Description:

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

Treatment:

Dietary Supplement: I-Fiber Pearl