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Completed

NCT Number: NCT06203834

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

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

Completed

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, South, 402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I-Fiber Pearl

Dietary Supplement

Eat 200g for once, and once a day.

Placebo

Dietary Supplement

Eat 200g for once, and once a day.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • ITSWAY BIOTECH INC.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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