ObesityNCT03774381
Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
A study testing Bifidobacterium breve B-3 in people with Obesity, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bifidobacterium breve B-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 1 Aug 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 27~30 kg/m2
Who cannot join
- Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
- Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
- Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- Those who are treated with hypothyroidism or hyperthyroidism
- Creatinine levels: more than twice the normal upper limit
- Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the normal upper limit
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- Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
- Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
- Participated in the commercial obesity program within the last 3 months.
- If you have participated or are planning to participate in another clinical trial within the past month If yes
- Alcohol abuser
- Smoking abstinence within 3 months
- If they are pregnant or lactating or have a pregnancy plan during the clinical trial
- Those with allergic reactions to the constituent food
- Any person deemed inappropriate by the researcher for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, 50612
About this study
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults
Read the detailed description
Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.
- Conditions
- Obesity
- Being tested
- Bifidobacterium breve B-3, Control group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium breve B-3Dietary supplement
160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
Control groupDietary supplement
160 mg of placebo is orally administered per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium breve B-3 group | Experimental | 160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks. Receives: Dietary Supplement: Bifidobacterium breve B-3 |
| Control group | Placebo comparator | 160 mg of placebo was orally administered per day for 12 weeks. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
dual energy x-ray absorptiometry (DEXA)
Measured: Change from baseline body fat at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Sep 2018
- Primary completion31 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774381
- Sponsor's protocol ID
- 02-2018-016
- Status last verified
- Sep 2019
- First submitted
- 11 Dec 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
- ClinicalTrials.gov ID
- NCT03774381
- Acronym / sponsor ID
- 02-2018-016
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 13 Dec 2018 (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.
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults
Detailed description
Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium breve B-3 group | Experimental | Dietary Supplement: Bifidobacterium breve B-3160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks. |
| Control group | Placebo comparator | Dietary Supplement: Control group160 mg of placebo was orally administered per day for 12 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 27~30 kg/m2
Key exclusion criteria (15 listed)
- Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
- Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
- Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- Those who are treated with hypothyroidism or hyperthyroidism
- Creatinine levels: more than twice the normal upper limit
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 |
|---|---|---|
| Bifidobacterium breve B-3160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks. | Dietary supplement | Bifidobacterium breve B-3 group |
| Control group160 mg of placebo is orally administered per day for 12 weeks. | Dietary supplement | Control group |
Primary outcome
Body fat
Time frame: Change from baseline body fat at 12 weeks
dual energy x-ray absorptiometry (DEXA)
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 11 Sep 2019.
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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.
Sang Yeoup Lee, MD principal investigator
Pusan National University Yangsan 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 Bifidobacterium breve B-3 in people with Obesity, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 15 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 11 Sep 2019. 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 South Korea. 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 fat (time frame: Change from baseline body fat at 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 11 Sep 2019.