Overweight and ObesityNCT05620667
Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat.
A study testing immature ponkan (Citrus reticulate) extract and time restricted feeding in people with Overweight and Obesity, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- immature ponkan (Citrus reticulate) extract and time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Oct 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University
Taichung, South, 402
Chin-Lin Hsu, Professor, 04-24730022 ext. 12222, clhsu@csmu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- immature ponkan (Citrus reticulate) extract, placebo, time restricted feeding
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immature ponkan (Citrus reticulate) extractDietary supplement
Drink 25mL for once, and once a day.
placeboDietary supplement
Drink 25mL for once, and once a day.
time restricted feedingBehavioural
Controlling a shortened period of time for eating within 8 hour each day.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day. Receives: Dietary Supplement: placebo |
| immature ponkan (Citrus reticulate) extract | Experimental | Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day. Receives: Dietary Supplement: immature ponkan (Citrus reticulate) extract |
| immature ponkan (Citrus reticulate) extract with time restricted feeding | Experimental | Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding. Receives: Dietary Supplement: immature ponkan (Citrus reticulate) extract; Behavioral: time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body weight at week 8
Compared the difference of body weight between the week 8 and 0.
Measured: Week 0, Week 8
Secondary outcomes (1)
Change from baseline body fat at week 8
Compared the difference of body fat between the week 8 and 0.
Measured: Week 0, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start28 Oct 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- TCI Co., Ltd.
- Responsible party
- Principal investigator, Chin-Lin Hsu, Chung Shan Medical University
- Investigators
- Yu-Jou Chien, PhD student, Principal investigator, Chung Shan Medical UniversityYing-Ching Feng, MS student, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620667
- Sponsor's protocol ID
- CS2-22066
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Citrus Reticulate Unripe Fruit Extraction on Body Weight and Body Fat in Human Trial.
- ClinicalTrials.gov ID
- NCT05620667
- Acronym / sponsor ID
- CS2-22066
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- TCI Co., Ltd.
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placeboPlacebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day. |
| immature ponkan (Citrus reticulate) extract | Experimental | Dietary Supplement: immature ponkan (Citrus reticulate) extractImmature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day. |
| immature ponkan (Citrus reticulate) extract with time restricted feeding | Experimental | Dietary Supplement: immature ponkan (Citrus reticulate) extract, Behavioral: time restricted feedingImmature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immature ponkan (Citrus reticulate) extractDrink 25mL for once, and once a day. | Dietary supplement | immature ponkan (Citrus reticulate) extract, immature ponkan (Citrus reticulate) extract with time restricted feeding |
| placeboDrink 25mL for once, and once a day. | Dietary supplement | placebo |
| time restricted feedingControlling a shortened period of time for eating within 8 hour each day. | Behavioural | immature ponkan (Citrus reticulate) extract with time restricted feeding |
Primary outcome
Change from baseline body weight at week 8
Time frame: Week 0, Week 8
Compared the difference of body weight between the week 8 and 0.
1 secondary outcome
Change from baseline body fat at week 8
Time frame: Week 0, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Jou Chien, PhD student principal investigator
Chung Shan Medical University
Ying-Ching Feng, MS student principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immature ponkan (Citrus reticulate) extract and time restricted feeding in people with Overweight and Obesity, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Lin Hsu, Professor (04-24730022 ext. 12222, clhsu@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body weight at week 8 (time frame: Week 0, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.