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

Not Applicable

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: immature ponkan (Citrus reticulate) extract; Dietary Supplement: placebo; Behavioral: time restricted feeding

• Registration Number: NCT05620667
• Lead Sponsor: Chung Shan Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-17
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immature ponkan (Citrus reticulate) extract with time restricted feeding	immature ponkan (Citrus reticulate) extract	Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.
immature ponkan (Citrus reticulate) extract	immature ponkan (Citrus reticulate) extract	Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.
immature ponkan (Citrus reticulate) extract with time restricted feeding	time restricted feeding	Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.
placebo	placebo	Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline body weight at week 8	Week 0, Week 8	Compared the difference of body weight between the week 8 and 0.

Secondary Outcome Measures

Name	Time	Method
Change from baseline body fat at week 8	Week 0, Week 8	Compared the difference of body fat between the week 8 and 0.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, South, Taiwan