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

NCT ID: NCT05620667

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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placebo

Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Drink 25mL for once, and once a day.

immature ponkan (Citrus reticulate) extract

Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.

Group Type EXPERIMENTAL

immature ponkan (Citrus reticulate) extract

Intervention Type DIETARY_SUPPLEMENT

Drink 25mL for once, and once a day.

immature ponkan (Citrus reticulate) extract with time restricted feeding

Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.

Group Type EXPERIMENTAL

immature ponkan (Citrus reticulate) extract

Intervention Type DIETARY_SUPPLEMENT

Drink 25mL for once, and once a day.

time restricted feeding

Intervention Type BEHAVIORAL

Controlling a shortened period of time for eating within 8 hour each day.

Interventions

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immature ponkan (Citrus reticulate) extract

Drink 25mL for once, and once a day.

Intervention Type DIETARY_SUPPLEMENT

placebo

Drink 25mL for once, and once a day.

Intervention Type DIETARY_SUPPLEMENT

time restricted feeding

Controlling a shortened period of time for eating within 8 hour each day.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin-Lin Hsu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Jou Chien, PhD student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Ying-Ching Feng, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu, Professor

Role: CONTACT

04-24730022 ext. 12222

Facility Contacts

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Chin-Lin Hsu, Professor

Role: primary

04-24730022 ext. 12222

Other Identifiers

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CS2-22066

Identifier Type: -

Identifier Source: org_study_id

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