Body WeightNCT05805488
Evaluation of the Body Slimming Effect of TCI904
A study testing TCI904 sachet in people with Body Weight and Metabolic Syndrome, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Metabolic Syndrome
- What is being tested?
- TCI904 sachet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 20
- BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%.
- History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol LDL-C > 130 mg/dL or triglyceride TG > 130 mg/dL), high-density lipoprotein cholesterol HDL-C < 40 mg/dL.
- If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%).
- Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.
Who cannot join
- History of diabetic ketoacidosis.
- Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months.
- Known acute infectious illness within the past month with > 7 days of antibiotics.
- Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month.
- Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
- History of any cancer in the past 5 years or still receiving cancer treatment.
Show all 13Show fewer
- Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis.
- Patients with abnormal kidney function (eGFR < 30 mL/min/1.73 m^2).
- Patients with a history of alcoholism.
- Have participated in any other interventional clinical research within the last month.
- Pregnant and lactating women.
- Known history of allergy to the test substance.
- Patients who are judged inappropriate by the trial host.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904
To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming
- Conditions
- Body Weight, Metabolic Syndrome
- Being tested
- Placebo sachet, TCI904 sachet
- Medical subject headings
- Body Weight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo sachetDietary supplement
consume 1 sachet per day
TCI904 sachetDietary supplement
Also called Lactobacillus delbrueckii ssp. bulgaricus TCI904
consume 1 sachet per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo sachet | Placebo comparator | Not described Receives: Dietary Supplement: Placebo sachet |
| TCI904 sachet | Experimental | Not described Receives: Dietary Supplement: TCI904 sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of body weight (kg)
The body weight was assessed by Body Composition Monitor
Measured: Week 0, week 12
The change of BMI (kg/m^2)
The BMI was assessed by Body Composition Monitor
Measured: Week 0, week 12
The change of body fat rate (%)
The body fat rate was assessed by Body Composition Monitor
Measured: Week 0, week 12
Secondary outcomes (17)
The change of total cholesterol
Fasting venous blood was sampled to measure concentrations of total cholesterol
Measured: Week 0, week 12
The change of triglyceride
Fasting venous blood was sampled to measure concentrations of triglyceride
Measured: Week 0, week 12
The change of HDL-C
Fasting venous blood was sampled to measure concentrations of HDL-C
Measured: Week 0, week 12
The change of LDL-C
Fasting venous blood was sampled to measure concentrations of LDL-C
Measured: Week 0, week 12
The change of blood glucose
Fasting venous blood was sampled to measure concentrations of glucose
Measured: Week 0, week 12
The change of C-reactive protein
Fasting venous blood was sampled to measure concentrations of C-reactive protein
Measured: Week 0, week 12
The change of insulin
Fasting venous blood was sampled to measure concentrations of insulin
Measured: Week 0, week 12
The change of HbA1c
Fasting venous blood was sampled to measure concentrations of HbA1c
Measured: Week 0, week 12
The change of TNF-alpha
Fasting venous blood was sampled to measure concentrations of TNF-alpha
Measured: Week 0, week 12
The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)
Fasting venous blood was sampled to measure concentrations of HIF-1alpha
Measured: Week 0, week 12
The change of cyclooxygenase-2 (COX-2)
Fasting venous blood was sampled to measure concentrations of COX-2
Measured: Week 0, week 12
The change of Matrix metalloproteinase (MMP)
Fasting venous blood was sampled to measure concentrations of MMP
Measured: Week 0, week 12
The change of aspartate aminotransferase
Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase
Measured: Week 0, week 12
The change of alanine aminotransferase
Fasting venous blood was sampled to measure concentrations of alanine aminotransferase
Measured: Week 0, week 12
The change of albumin
Fasting venous blood was sampled to measure concentrations of albumin
Measured: Week 0, week 12
The change of creatine
Fasting venous blood was sampled to measure concentrations of creatine
Measured: Week 0, week 12
The change of blood urea nitrogen (BUN)
Fasting venous blood was sampled to measure concentrations of BUN
Measured: Week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Oct 2021
- Primary completion31 Jan 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang-Chang Wu, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805488
- Sponsor's protocol ID
- CMUH110-REC2-070
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904
- ClinicalTrials.gov ID
- NCT05805488
- Acronym / sponsor ID
- CMUH110-REC2-070
- Conditions
- Body Weight, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2023 (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 efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo sachet | Placebo comparator | Dietary Supplement: Placebo sachet |
| TCI904 sachet | Experimental | Dietary Supplement: TCI904 sachet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 20
- BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%.
- History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol LDL-C > 130 mg/dL or triglyceride TG > 130 mg/dL), high-density lipoprotein cholesterol HDL-C < 40 mg/dL.
- If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%).
- Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.
Key exclusion criteria (13 listed)
- History of diabetic ketoacidosis.
- Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months.
- Known acute infectious illness within the past month with > 7 days of antibiotics.
- Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month.
- Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
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 |
|---|---|---|
| Placebo sachetconsume 1 sachet per day | Dietary supplement | Placebo sachet |
| TCI904 sachetAlso: Lactobacillus delbrueckii ssp. bulgaricus TCI904consume 1 sachet per day | Dietary supplement | TCI904 sachet |
Primary outcome
The change of body weight (kg)
Time frame: Week 0, week 12
The body weight was assessed by Body Composition Monitor
The change of BMI (kg/m^2)
Time frame: Week 0, week 12
The BMI was assessed by Body Composition Monitor
The change of body fat rate (%)
Time frame: Week 0, week 12
The body fat rate was assessed by Body Composition Monitor
17 secondary outcomes
The change of total cholesterol
Time frame: Week 0, week 12
The change of triglyceride
Time frame: Week 0, week 12
The change of HDL-C
Time frame: Week 0, week 12
The change of LDL-C
Time frame: Week 0, week 12
The change of blood glucose
Time frame: Week 0, week 12
The change of C-reactive protein
Time frame: Week 0, week 12
The change of insulin
Time frame: Week 0, week 12
The change of HbA1c
Time frame: Week 0, week 12
The change of TNF-alpha
Time frame: Week 0, week 12
The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)
Time frame: Week 0, week 12
The change of cyclooxygenase-2 (COX-2)
Time frame: Week 0, week 12
The change of Matrix metalloproteinase (MMP)
Time frame: Week 0, week 12
The change of aspartate aminotransferase
Time frame: Week 0, week 12
The change of alanine aminotransferase
Time frame: Week 0, week 12
The change of albumin
Time frame: Week 0, week 12
The change of creatine
Time frame: Week 0, week 12
The change of blood urea nitrogen (BUN)
Time frame: Week 0, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Yang-Chang Wu principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI904 sachet in people with Body Weight and Metabolic Syndrome, 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 10 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 weight (kg) (time frame: Week 0, week 12). The study lists 3 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 10 Apr 2023.