Overweight and ObesityNCT06244186
The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
A study testing Probiotics in people with Overweight and Obesity, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2021to 3 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years old
- Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
- Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol > 130 mg/dL or triglycerides > 130 mg/dL), high-density lipoprotein cholesterol < 40 mg/dL
- If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
- Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form
Who cannot join
- History of diabetic ketoacidosis
- Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
- Occurrence of acute infectious diseases within the last month and antibiotic use for > 7 days
- Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
- Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
- History of any cancer or undergoing cancer treatment in the past 5 years
Show all 13Show fewer
- Abnormal liver function (GOT or GPT greater than 3 times the normal upper limit) or liver cirrhosis
- Impaired kidney function (eGFR < 30 mL/min/1.73 m2)
- History of alcohol abuse
- Participation in any other interventional clinical research within the last month
- Pregnant and breastfeeding women
- History of allergy to the investigational product
- Participants deemed unsuitable for inclusion by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.
Read the detailed description
The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.
A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.
- Conditions
- Overweight and Obesity
- Being tested
- Probiotics, Placebo
- Keywords
- Lactobacillus delbrueckii subsp. Bulgaricus, weight reduction, health care
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Probiotics contains a probiotic known as Lactobacillus delbrueckii subsp. Bulgaricus, a key bacterium utilized in the production of yogurt, cheeses, and various naturally fermented products. Studies suggest that the metabolites of Lactobacillus bulgaricus can enhance immunity and digestion, reduce the risk of infection, and lower blood cholesterol levels. The composition of probiotics has been developed by TCI CO., Ltd.
PlaceboDietary supplement
Placebo is provided by TCI CO., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Take one packet (6 grams) of powder orally once daily. The probiotics contain fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, silicon dioxide, and Lactobacillus delbrueckii subsp. Bulgaricus. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo contains fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, and silicon dioxide. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Comparing the changes between Day 0 and Day 84
Measured: 84 days
Body fat
Comparing the changes between Day 0 and Day 84
Measured: 84 days
BMI
Comparing the changes between Day 0 and Day 84
Measured: 84 days
Secondary outcomes (4)
ALT and AST (U/L) in Blood composition
Comparing the changes in ALT and AST (alanine aminotransferase, aspartate aminotransferase) in the blood between Day 0 and Day 84
Measured: 84 days
CRE, BUN and GLU-AC (mg/dL) in Blood composition
Comparing the changes in CRE, BUN, and GLU-AC (creatinine, blood urea nitrogen, fasting blood glucose) in the blood between Day 0 and Day 84
Measured: 84 days
Changes in glycated hemoglobin
Comparing the changes in hemoglobin A1c between Day 0 and Day 84.
Measured: 84 days
Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition
Comparing the changes in CHOL, TG, HDL, and LDL-C (cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) between Day 0 and Day 84.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start10 Sep 2021
- Primary completion1 Nov 2022
- Study completion3 Nov 2023
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.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Participants were randomly assigned to either the placebo or probiotics group, receiving continuous administration for 12 weeks. Measurements of weight, BMI, and body fat were taken on days 0, 28, 56, and 84 of the treatment period. Additionally, 15 mL of fasting blood was drawn on both the first and 84th day.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TCI Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kuo-Chin Huang, PhD, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244186
- Sponsor's protocol ID
- CMUH110-REC2-070
- Status last verified
- Feb 2024
- First submitted
- 2 Jan 2024
- Last updated
- 6 Feb 2024
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
- ClinicalTrials.gov ID
- NCT06244186
- Acronym / sponsor ID
- CMUH110-REC2-070
- Conditions
- Overweight and Obesity
- Keywords
- Lactobacillus delbrueckii subsp. Bulgaricus, weight reduction, health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- TCI Co., Ltd.
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 6 Feb 2024 (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 evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.
Detailed description
The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.
A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the placebo or probiotics group, receiving continuous administration for 12 weeks. Measurements of weight, BMI, and body fat were taken on days 0, 28, 56, and 84 of the treatment period. Additionally, 15 mL of fasting blood was drawn on both the first and 84th day.
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsTake one packet (6 grams) of powder orally once daily. The probiotics contain fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, silicon dioxide, and Lactobacillus delbrueckii subsp. Bulgaricus. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo contains fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, and silicon dioxide. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 20 years old
- Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
- Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol > 130 mg/dL or triglycerides > 130 mg/dL), high-density lipoprotein cholesterol < 40 mg/dL
- If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
- Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form
Key exclusion criteria (13 listed)
- History of diabetic ketoacidosis
- Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
- Occurrence of acute infectious diseases within the last month and antibiotic use for > 7 days
- Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
- Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
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 |
|---|---|---|
| ProbioticsProbiotics contains a probiotic known as Lactobacillus delbrueckii subsp. Bulgaricus, a key bacterium utilized in the production of yogurt, cheeses, and various naturally fermented products. Studies suggest that the metabolites of Lactobacillus bulgaricus can enhance immunity and digestion, reduce the risk of infection, and lower blood cholesterol levels. The composition of probiotics has been developed by TCI CO., Ltd. | Dietary supplement | Probiotics |
| PlaceboPlacebo is provided by TCI CO., Ltd. | Dietary supplement | Placebo |
Primary outcome
Body weight
Time frame: 84 days
Comparing the changes between Day 0 and Day 84
Body fat
Time frame: 84 days
Comparing the changes between Day 0 and Day 84
BMI
Time frame: 84 days
Comparing the changes between Day 0 and Day 84
4 secondary outcomes
ALT and AST (U/L) in Blood composition
Time frame: 84 days
CRE, BUN and GLU-AC (mg/dL) in Blood composition
Time frame: 84 days
Changes in glycated hemoglobin
Time frame: 84 days
Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition
Time frame: 84 days
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 6 Feb 2024.
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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.
Kuo-Chin Huang, PhD study director
China Medical 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 Probiotics in people with Overweight and Obesity, run by China Medical University Hospital 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 6 Feb 2024. 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?
Body weight (time frame: 84 days). 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 6 Feb 2024.