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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
immature ponkan (Citrus reticulate) extract
placebo
time restricted feeding
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chung Shan Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

immature ponkan (Citrus reticulate) extract

immature ponkan (Citrus reticulate) extract with time restricted feeding

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline body weight at week 8
Compared the difference of body weight between the week 8 and 0.

Secondary Outcome Measures

Change from baseline body fat at week 8
Compared the difference of body fat between the week 8 and 0.

Full Information

First Posted
November 10, 2022
Last Updated
November 10, 2022
Sponsor
Chung Shan Medical University
Collaborators
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05620667
Brief Title
Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.
Official Title
Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
Collaborators
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.
Arm Title
immature ponkan (Citrus reticulate) extract
Arm Type
Experimental
Arm Description
Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.
Arm Title
immature ponkan (Citrus reticulate) extract with time restricted feeding
Arm Type
Experimental
Arm Description
Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.
Intervention Type
Dietary Supplement
Intervention Name(s)
immature ponkan (Citrus reticulate) extract
Intervention Description
Drink 25mL for once, and once a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Drink 25mL for once, and once a day.
Intervention Type
Behavioral
Intervention Name(s)
time restricted feeding
Intervention Description
Controlling a shortened period of time for eating within 8 hour each day.
Primary Outcome Measure Information:
Title
Change from baseline body weight at week 8
Description
Compared the difference of body weight between the week 8 and 0.
Time Frame
Week 0, Week 8
Secondary Outcome Measure Information:
Title
Change from baseline body fat at week 8
Description
Compared the difference of body fat between the week 8 and 0.
Time Frame
Week 0, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Lin Hsu, Professor
Phone
04-24730022
Ext
12222
Email
clhsu@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Jou Chien, PhD student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying-Ching Feng, MS student
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
State/Province
South
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Lin Hsu, Professor
Phone
04-24730022
Ext
12222
Email
clhsu@csmu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

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