OverweightNCT04496895
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
A study testing orange peel fermentation in people with Overweight and Fatty Liver Disease, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess whether orange peel fermentation has the effect of reducing body fat in adults Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Fatty Liver Disease
- What is being tested?
- orange peel fermentation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Nov 2022to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
- For those with BMI ≥ 24 or fatty liver, male body fat ≥ 25%, female body fat ≥ 30%.
- Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).
Who cannot join
- Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person who has received major surgery or bariatric surgery (according to medical history).
- I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 114
chi fu chiang, Ph.D
About this study
To assess whether orange peel fermentation has the effect of reducing body fat in adults
Read the detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.
- Conditions
- Overweight, Fatty Liver Disease
- Being tested
- Placebo, orange peel fermentation
- Medical subject headings
- Overweight, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
consume 1 sachet per day for 2 months
orange peel fermentationDietary supplement
Also called Citrus reticulata enzymes, Meta-up!, Tangerlean
consume 1 sachet per day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | consume 1 sachet per day for 2 months Receives: Dietary Supplement: Placebo |
| orange peel fermentation | Experimental | consume 1 sachet per day for 2 months Receives: Dietary Supplement: orange peel fermentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of body fat mass
The body fat mass (kg) was assessed by InBody770
Measured: Weeks 0, 4 and 8
The change of Triglyceride
Venous blood was sampled to measure concentrations of Triglyceride
Measured: Weeks 0, 4 and 8
The change of Total cholestrol
Venous blood was sampled to measure concentrations of Total cholestrol
Measured: Weeks 0, 4 and 8
The change of HDL-cholestrol
Venous blood was sampled to measure concentrations of HDL-cholestrol
Measured: Weeks 0, 4 and 8
The change of LDL-cholestrol
Venous blood was sampled to measure concentrations of LDL-cholestrol
Measured: Weeks 0, 4 and 8
The change of body mass index (BMI)
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
Measured: Weeks 0, 4 and 8
The change of body fat percentage
The body fat percentage (%) was assessed by InBody770.
Measured: Weeks 0, 4 and 8
The change of visceral fat
The visceral fat (10 cm^2) was assessed by InBody770.
Measured: Weeks 0, 4 and 8
The change of fasting glycemia
Venous blood was sampled to measure concentrations of fasting glycemia
Measured: Weeks 0, 4 and 8
The change of aspartate aminotransferase
Venous blood was sampled to measure concentrations of aspartate aminotransferase
Measured: Weeks 0, 4 and 8
The change of alanine aminotransferase
Venous blood was sampled to measure concentrations of alanine aminotransferase
Measured: Weeks 0, 4 and 8
The change of albumin
Venous blood was sampled to measure concentrations of creatine
Measured: Weeks 0, 4 and 8
The change of creatine
Venous blood was sampled to measure concentrations of creatine
Measured: Weeks 0, 4 and 8
The change of uric acid
Venous blood was sampled to measure concentrations of uric acid
Measured: Weeks 0, 4 and 8
The change of white blood cell
Venous blood was sampled to measure concentrations of white blood cell
Measured: Weeks 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start12 Nov 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LIOU JYH-MING, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496895
- Sponsor's protocol ID
- 201912030RSA
- Status last verified
- May 2026
- First submitted
- 26 Jul 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
- ClinicalTrials.gov ID
- NCT04496895
- Acronym / sponsor ID
- 201912030RSA
- Conditions
- Overweight, Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Aug 2020 (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.
To assess whether orange peel fermentation has the effect of reducing body fat in adults
Detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboconsume 1 sachet per day for 2 months |
| orange peel fermentation | Experimental | Dietary Supplement: orange peel fermentationconsume 1 sachet per day for 2 months |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
- For those with BMI ≥ 24 or fatty liver, male body fat ≥ 25%, female body fat ≥ 30%.
- Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).
Key exclusion criteria (3 listed)
- Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person who has received major surgery or bariatric surgery (according to medical history).
- I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).
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 |
|---|---|---|
| Placeboconsume 1 sachet per day for 2 months | Dietary supplement | Placebo |
| orange peel fermentationAlso: Citrus reticulata enzymes, Meta-up!, Tangerleanconsume 1 sachet per day for 2 months | Dietary supplement | orange peel fermentation |
Primary outcome
The change of body fat mass
Time frame: Weeks 0, 4 and 8
The body fat mass (kg) was assessed by InBody770
The change of Triglyceride
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrol
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of Total cholestrol
The change of HDL-cholestrol
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of LDL-cholestrol
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of LDL-cholestrol
The change of body mass index (BMI)
Time frame: Weeks 0, 4 and 8
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) were assessed by InBody770.
The change of body fat percentage
Time frame: Weeks 0, 4 and 8
The body fat percentage (%) was assessed by InBody770.
The change of visceral fat
Time frame: Weeks 0, 4 and 8
The visceral fat (10 cm^2) was assessed by InBody770.
The change of fasting glycemia
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of fasting glycemia
The change of aspartate aminotransferase
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of alanine aminotransferase
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of albumin
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of creatine
The change of creatine
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of creatine
The change of uric acid
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of uric acid
The change of white blood cell
Time frame: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of white blood cell
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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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.
LIOU JYH-MING, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orange peel fermentation in people with Overweight and Fatty Liver Disease, run by TCI Co., Ltd. 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUANG YU-JYUN (0934173838, nneder34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of body fat mass (time frame: Weeks 0, 4 and 8). The study lists 15 primary outcomes in all. 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 29 May 2026.