Weight LossNCT04492605
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
A study testing TCI378 Probiotics and TCI507 Probiotics in people with Weight Loss, run by TCI Co., Ltd. at 2 sites in Taiwan.
Trial summary
To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- TCI378 Probiotics and TCI507 Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesTaiwan
- Study dates
- 9 Mar 2022to 31 May 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 25 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.
- BMI ≥ 24 or 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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person who has undergone major surgery or bariatric surgery (according to medical history).
- Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, Taiwan, 114
National Taiwan University Hospital
Taipei
About this study
To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy 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 person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.
- Conditions
- Weight Loss
- Being tested
- Placebo, TCI378 Probiotics, TCI507 Probiotics
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
consume 1 capsule per day for 2 months
TCI378 ProbioticsDietary supplement
Also called InnerLean
consume 1 capsule per day for 2 months
TCI507 ProbioticsDietary supplement
Also called bettrcardio
consume 1 capsule per day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| TCI378 Probiotics | Experimental | TCI378 Probiotics Receives: Dietary Supplement: TCI378 Probiotics |
| TCI507 Probiotics | Experimental | TCI507 Probiotics Receives: Dietary Supplement: TCI507 Probiotics |
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
Secondary outcomes (7)
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 albumin
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 posted30 Jul 2020
- Study start9 Mar 2022
- Primary completion16 Oct 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LIOU JYH-MING, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492605
- Sponsor's protocol ID
- 201912029RSA
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2020
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
- ClinicalTrials.gov ID
- NCT04492605
- Acronym / sponsor ID
- 201912029RSA
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 30 Jul 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 the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy 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 person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| TCI378 Probiotics | Experimental | Dietary Supplement: TCI378 ProbioticsTCI378 Probiotics |
| TCI507 Probiotics | Experimental | Dietary Supplement: TCI507 ProbioticsTCI507 Probiotics |
Who may qualify
- Ages
- 25 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.
- BMI ≥ 24 or 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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person who has undergone major surgery or bariatric surgery (according to medical history).
- Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 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 capsule per day for 2 months | Dietary supplement | Placebo |
| TCI378 ProbioticsAlso: InnerLeanconsume 1 capsule per day for 2 months | Dietary supplement | TCI378 Probiotics |
| TCI507 ProbioticsAlso: bettrcardioconsume 1 capsule per day for 2 months | Dietary supplement | TCI507 Probiotics |
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.
7 secondary outcomes
The change of fasting glycemia
Time frame: Weeks 0, 4 and 8
The change of aspartate aminotransferase
Time frame: Weeks 0, 4 and 8
The change of alanine aminotransferase
Time frame: Weeks 0, 4 and 8
The change of albumin
Time frame: Weeks 0, 4 and 8
The change of creatine
Time frame: Weeks 0, 4 and 8
The change of uric acid
Time frame: Weeks 0, 4 and 8
The change of white blood cell
Time frame: Weeks 0, 4 and 8
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.
- Individual participant dataSharing planned: No
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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.
LIOU JYH-MING principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI378 Probiotics and TCI507 Probiotics in people with Weight Loss, run by TCI Co., Ltd. at 2 sites 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: under way, not looking for participants, 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 8 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.