Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2022
CompletedFirst Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedNovember 17, 2022
November 1, 2022
6 months
November 10, 2022
November 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change from baseline body fat at week 8
Week 0, Week 8
Study Arms (3)
placebo
PLACEBO COMPARATORPlacebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day.
immature ponkan (Citrus reticulate) extract
EXPERIMENTALImmature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day.
immature ponkan (Citrus reticulate) extract with time restricted feeding
EXPERIMENTALImmature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding.
Interventions
Drink 25mL for once, and once a day.
Controlling a shortened period of time for eating within 8 hour each day.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chung Shan Medical Universitylead
- TCI Co., Ltd.collaborator
Study Sites (1)
Chung Shan Medical University
Taichung, South, 402, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Jou Chien, PhD student
Chung Shan Medical University
- PRINCIPAL INVESTIGATOR
Ying-Ching Feng, MS student
Chung Shan Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 17, 2022
Study Start
October 28, 2022
Primary Completion
April 30, 2023
Study Completion
August 31, 2023
Last Updated
November 17, 2022
Record last verified: 2022-11