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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620667
Other study ID # CS2-22066
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2022
Est. completion date August 31, 2023

Study information

Verified date November 2022
Source Chung Shan Medical University
Contact Chin-Lin Hsu, Professor
Phone 04-24730022
Email clhsu@csmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.


Description:

This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - male or female - aged 20-60 years old - body mass index is greater than or equal to 24 kg/m2, or body fat more than 30% 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
immature ponkan (Citrus reticulate) extract
Drink 25mL for once, and once a day.
placebo
Drink 25mL for once, and once a day.
Behavioral:
time restricted feeding
Controlling a shortened period of time for eating within 8 hour each day.

Locations

Country Name City State
Taiwan Chung Shan Medical University Taichung South

Sponsors (2)

Lead Sponsor Collaborator
Chung Shan Medical University TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline body weight at week 8 Compared the difference of body weight between the week 8 and 0. Week 0, Week 8
Secondary Change from baseline body fat at week 8 Compared the difference of body fat between the week 8 and 0. Week 0, Week 8
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