Overweight or ObesityNCT06305650
Probiotic Influence on Obesity-Related Lipidemia
A study testing Probiotic in people with Overweight or Obesity, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 30 Jul 2024
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 28 kg/m2;
- Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
- Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
- Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;
Who cannot join
- Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
- Patients with severe allergies and immune deficiency;
- Women who are pregnant, breastfeeding or planning to become pregnant;
- Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
- People who have used antibiotics in the past two weeks;
- Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;
- Have used laxatives or fiber supplements in the past 6 weeks;
- Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals
This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.
- Conditions
- Overweight or Obesity
- Being tested
- Probiotic
- Keywords
- Probiotic, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Through oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | one bag/day BBr60, before meals Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Maltodextrin, one bag/day, before meals Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on body mass index (BMI) values.
After the probiotic intervention, the change in body mass index (BMI) from baseline in obese/overweight individuals will be calculated. BMI is measured by dividing a person's weight in kilograms by the square of their height in meters (kg/m^2).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Mar 2024
- Primary completion20 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305650
- Sponsor's protocol ID
- WK2024001
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT06305650
- Acronym / sponsor ID
- WK2024001
- Conditions
- Overweight or Obesity
- Keywords
- Probiotic, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Mar 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.
This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probioticone bag/day BBr60, before meals |
| Placebo group | Placebo comparator | Dietary Supplement: ProbioticMaltodextrin, one bag/day, before meals |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) ≥ 28 kg/m2;
- Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
- Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
- Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;
Key exclusion criteria (8 listed)
- Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
- Patients with severe allergies and immune deficiency;
- Women who are pregnant, breastfeeding or planning to become pregnant;
- Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
- People who have used antibiotics in the past two weeks;
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 |
|---|---|---|
| ProbioticThrough oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis. | Dietary supplement | Placebo group, Probiotic group |
Primary outcome
Effect on body mass index (BMI) values.
Time frame: 12 weeks
After the probiotic intervention, the change in body mass index (BMI) from baseline in obese/overweight individuals will be calculated. BMI is measured by dividing a person's weight in kilograms by the square of their height in meters (kg/m^2).
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 19 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Overweight or Obesity, run by Wecare Probiotics Co., Ltd. at 1 site in China.
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 8 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 19 Sep 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 China. 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?
Effect on body mass index (BMI) values. (time frame: 12 weeks). 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 19 Sep 2024.