Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.

Overweight and Obesity Clinical Trial

Official title:

Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620667
• Other study ID #: CS2-22066
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity

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