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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: immature ponkan (Citrus reticulate) extract; Behavioral: time restricted feeding

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chin-Lin Hsu, Professor; Phone Number: 12222 04-24730022; Email: clhsu@csmu.edu.tw

Study Locations

• Taiwan
  • South
    • Taichung, South, Taiwan, 402
      • Recruiting
      • Chung Shan Medical University
      • Contact: Chin-Lin Hsu, Professor; Phone Number: 12222 04-24730022; Email: clhsu@csmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.	Dietary supplement: placebo; Drink 25mL for once, and once a day.
Experimental: immature ponkan (Citrus reticulate) extract; Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.	Dietary supplement: immature ponkan (Citrus reticulate) extract; Drink 25mL for once, and once a day.
Experimental: 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.	Dietary supplement: immature ponkan (Citrus reticulate) extract; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline body fat at week 8	Compared the difference of body fat between the week 8 and 0.	Week 0, Week 8

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Collaborators: TCI Co., Ltd.
• Investigators: Principal Investigator: Yu-Jou Chien, PhD Student, Chung Shan Medical University; Principal Investigator: Ying-Ching Feng, MS student, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: CS2-22066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No