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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203834
• Other study ID #: CS2-23093
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Chung Shan Medical University
• Contact: Chin-Lin Hsu
• Phone: 04-24730022
• Email: clhsu[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• I-Fiber Pearl
Eat 200g for once, and once a day.
• placebo
Eat 200g for once, and once a day.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung	South

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	ITSWAY BIOTECH INC.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline body weight at week 12	Compared the difference of body weight between the week 12 and 0.	Week 0, Week 12
Primary	Change from baseline body fat at week 12	Compared the difference of body fat between the week 12 and 0.	Week 0, Week 12