ObesityNCT04677738
Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
A study testing B. breve strain in people with Obesity and Overweight and Obesity, run by Morinaga Milk Industry Co., LTD at 1 site in Canada.
Trial summary
Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight and Obesity
- What is being tested?
- B. breve strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2020to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 20 and 65 years of age, inclusive
- BMI from 25.0 to 29.9 kg/m2, inclusive
- Female participants are not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
- Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
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- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
- Participants with the following body fat percentages as determined by Bioelectrical Impedance Analysis (BIA):
- Female: ≥ 30%
- Male: ≥ 20%
- Agrees to follow the diet and exercise guidelines for the duration of the study
- Willingness to complete questionnaires, records, and diaries associated with the study, to complete all clinic visits, and provide stool samples
- Provide voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results and physical exam as assessed by the Qualified Investigator (QI)
Who cannot join
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Current or history of any significant gastrointestinal disease requiring medication (e.g. GERD, gastroenteritis)
- Irregular sleep schedule
- Chronic diarrhea or constipation
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- Participants with hypertension and are on antihypertensive medication
- Type I or Type II diabetes
- Participants with hyperlipidemia and are on medication
- Self-reported sleep apnea
- Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom-free for 6 months
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis
- Major surgery in the past 3 months or individuals who have planned surgery during the trial period. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune-compromised
- Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
- Blood/bleeding disorders as determined by laboratory results
- Self-reported mental or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- Metal implants that may affect the DXA scan results will be assessed on a case- by-case basis by the QI.
- Current use of prescribed medications listed in Section Prescribed Medications as follows:
- Beta-blockers and thiazide diuretics (within 4 weeks of baseline)
- Weight loss medication (within 4 weeks of baseline)
- Lipid-lowering medications (within 4 weeks of baseline)
- Anticoagulants and coagulants (within 4 weeks of baseline)
- Sleep medication
- Selective serotonin reuptake inhibitors (SSRI)
- Antibiotics
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Proton pump inhibitors (PPIs)
- Metformin (unless on a stable dose for the last 6 months)
- Current use of over-the-counter medications, supplements, foods and/or drinks as follows:
- OTC NSAIDs (PRN use is acceptable)
- OTC blood pressure medication or supplements (within 4 weeks of
- baseline)
- Lipid metabolising supplements (within 4 weeks of baseline)
- Fish oil and omega-3 supplements
- Red yeast rice
- Plant sterols and stanols
- OTC medication or supplements marketed for weight loss (within 4 weeks
- of baseline)
- Vitamin E supplements (within 4 weeks of baseline)
- Coagulant/anticoagulant supplements (within 4 weeks of baseline)
- PPIs
- Use of cannabinoid products within 60 days of baseline. History of cannabis used will be assessed on a case by case basis by the QI
- Use of tobacco products within 60 days of baseline
- Self-reported alcohol or drug abuse within the last 12 months
- High alcohol intake (average of > 2 standard drinks per day or > 10 per week)
- Current employment that calls for shift work or have worked shift work in the last 3 weeks
- Participation in other clinical research trials 30 days prior to screening
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
- Individuals who are unable to give informed consent
- Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures, or which may pose a significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
Read the detailed description
In early adulthood, excess body weight is a risk factor associated with several health complications later on in life and probiotics have been used for decades for maintaining intestinal health, and in recent years probiotics have been proposed for weight management. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
- Conditions
- Obesity, Overweight and Obesity
- Being tested
- B. breve strain, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. breve strainDietary supplement
Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks.
PlaceboDietary supplement
Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. Receives: Dietary Supplement: Placebo |
| B. breve | Experimental | Capsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. Receives: Dietary Supplement: B. breve strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat Loss (g)
The difference in change in fat loss from baseline (g), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
Measured: 12 weeks from baseline
Change in Fat Loss (Percentage of Body Weight)
The difference in change in fat loss from baseline (percentage of body weight), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
Measured: 12 weeks from baseline
Secondary outcomes (39)
Body Weight
The difference in change from baseline between B. breve and placebo in body weight after 12 weeks of supplementation
Measured: 12 weeks from baseline
BMI
The difference in change from baseline between B. breve and placebo in BMI after 12 weeks of supplementation
Measured: 12 weeks from baseline
Android/Gynoid Fat Ratio
The difference in change from baseline between B. breve and placebo in android/gynoid fat ratio as assessed by DXA after 12 weeks of supplementation. Android-gynoid percent fat ratio is a pattern of body fat distribution that is associated with an increased risk for metabolic syndrome in healthy adults.
The measurement of android/gynoid fat ratio is defined as the ratio of the percentage of android fat to the percentage of gynoid fat.
Measured: 12 weeks from baseline
Muscle Mass (g)
The difference in change from baseline between B. breve and placebo in muscle mass (g) as assessed by DXA after 12 weeks of supplementation.
Measured: 12 weeks from baseline
Muscle Mass (Percentage of Body Weight)
The difference in change from baseline between B. breve and placebo in muscle mass (percentage of body weight) as assessed by DXA after 12 weeks of supplementation.
Measured: 12 weeks from baseline
Waist Circumference
The difference in change from baseline between B. breve and placebo in Waist circumference after 6 and 12 weeks of supplementation.
Measured: Baseline, 6 weeks and 12 weeks
Hip Circumference
The difference in change from baseline between B. breve and placebo in hip circumference after 6 and 12 weeks of supplementation.
Measured: Baseline, 6 weeks and 12 weeks
Waist/Hip Circumference Ratio
The difference in change from baseline between B. breve and placebo in waist/hip circumference ratio after 6 and 12 weeks of supplementation.
The waist/hip circumference ratio is defined as the percentage of waist circumference to hip circumference. The change in waist/hip circumference ratio from baseline to week 12 was calculated.
Measured: Baseline, 6 weeks and 12 weeks
Microbiota Analysis: Shannon Index
Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity.
The Shannon Index (or Shannon-Wiener/Shannon-Weaver index) is a widely used metric in ecology to quantify alpha diversity, which measures both species richness and evenness.
The value of the Shannon Index ranges from a minimum of zero, when there is only one species present (no diversity), to a maximum of ln(S), the natural logarithm of the total number of species (richness) to the base of Euler's number (e), which means all species are equally abundant. High values indicate a diverse, balanced community.
Measured: 12 weeks from baseline
Microbiota Analysis: Chao1 Index
Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity.
The Chao1 Index estimates total species richness, including rare/undetected species.
The value of the Chao1 Index ranges from a minimum, close to zero (suggesting reduced richness, often observed in dysbiosis) to a theoretically unbounded maximum, as it depends on rare species. Higher values indicate greater estimated species richness, generally associated with a healthier gut microbiome, linked to resilience, metabolic versatility, and protection against pathogens.
Measured: 12 weeks from baseline
Microbiota Analysis: Evenness Index
Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity.
The Evenness Index measures how evenly individuals are distributed among species in a community, such as the gut microbiome. It complements species richness (the number of species) to describe diversity, ranging from 0 (only a single species, meaning there is no evenness.) to 1, where 1 indicates perfect evenness, meaning all species are equally abundant.
Higher Evenness Index value (closer to 1) is generally considered better, as it suggests a more balanced and stable ecosystem. Conversely, lower value (closer to 0) is generally considered worse, as it suggests that a few species dominate the community, which can be associated with dysbiosis or an unhealthy gut microbiome.
Measured: 12 weeks from baseline
Microbiota Analysis: Observed ASV Index
Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity.
Observed ASV (Amplicon Sequence Variants) Index refers to the number of distinct Amplicon Sequence Variants (ASVs) detected in a sample. ASVs are highly resolved sequences used to identify and differentiate microbial taxa, providing finer resolution than traditional Operational Taxonomic Units (OTUs).
The range of Observed ASV Index in gut microbiome samples can range from a few hundred to several thousand, depending on several factors, including sample source, health status of the host, diet and lifestyle, as well as sequencing depth and methodology. Typically, higher Observed ASV Index indicates a more diverse microbial community, which can contribute to improved gut function and overall health.
Measured: 12 weeks from baseline
Microbiota Analysis: Faith's PD Index
Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity.
Faith's Phylogenetic Diversity (PD) is a measure used in ecology to quantify the biodiversity of a sample based on the phylogenetic tree. In the context of the gut microbiome, it specifically measures the diversity of microbial species by considering both the number of species present (richness) and the phylogenetic differences between them.
In practice, the values can range from very low (close to zero, indicating low microbial diversity linked to various health issues) to very high (indicates greater evolutionary diversity, which may enhance ecosystem resilience and is generally considered better in the context of gut microbiome health.).
Measured: 12 weeks from baseline
Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in weight in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in body mass index in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in total body fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in total body fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in muscle mass (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in muscle mass (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in android fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in android fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in gynoid fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in gynoid fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in android:gynoid fat ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in waist circumference in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in hip circumference, in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0
The change from baseline between B. breve and placebo in waist:hip circumference ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study.
Measured: 12 weeks from baseline
Total Cholesterol
The difference in change from baseline between B. breve and placebo in total cholesterol after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
HDL-cholesterol
The difference in change from baseline between B. breve and placebo in HDL-cholesterol after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
LDL-cholesterol
The difference in change from baseline between B. breve and placebo in LDL-cholesterol after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Triglycerides
The difference in change from baseline between B. breve and placebo in triglycerides after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Fasting Blood Glucose
The difference in change from baseline between B. breve and placebo in fasting blood glucose after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
HbA1c
The difference in change from baseline between B. breve and placebo in HbA1c after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Fasting Insulin
The difference in change from baseline between B. breve and placebo in fasting insulin after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Alkaline Phosphatase (ALP)
The difference in change from baseline between B. breve and placebo in ALP after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Gamma-glutamyl Transferase (GGT)
The difference in change from baseline between B. breve and placebo in GGT after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Alanine Aminotransferase (ALT)
The difference in change from baseline between B. breve and placebo in ALT after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Aspartate Transaminase (AST)
The difference in change from baseline between B. breve and placebo in AST after 12 weeks of supplementation.
Measured: Baseline and 12 weeks of supplementation
Frequency of Bowel Movements
The difference in change from baseline between B. breve and placebo in Frequency of bowel movements after 6 and 12 weeks of supplementation.
Measured: Baseline, 6 and 12 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start20 Aug 2020
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morinaga Milk Industry Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677738
- Sponsor's protocol ID
- 20BWHM
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2020
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
- ClinicalTrials.gov ID
- NCT04677738
- Acronym / sponsor ID
- 20BWHM
- Conditions
- Obesity, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Morinaga Milk Industry Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
Detailed description
In early adulthood, excess body weight is a risk factor associated with several health complications later on in life and probiotics have been used for decades for maintaining intestinal health, and in recent years probiotics have been proposed for weight management. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
| B. breve | Experimental | Dietary Supplement: B. breve strainCapsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female between 20 and 65 years of age, inclusive
- BMI from 25.0 to 29.9 kg/m2, inclusive
- Female participants are not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
- Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
Key exclusion criteria (54 listed)
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Current or history of any significant gastrointestinal disease requiring medication (e.g. GERD, gastroenteritis)
- Irregular sleep schedule
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 |
|---|---|---|
| B. breve strainProbiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. | Dietary supplement | B. breve |
| PlaceboPlacebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in Fat Loss (g)
Time frame: 12 weeks from baseline
The difference in change in fat loss from baseline (g), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
Change in Fat Loss (Percentage of Body Weight)
Time frame: 12 weeks from baseline
The difference in change in fat loss from baseline (percentage of body weight), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment
39 secondary outcomes
Body Weight
Time frame: 12 weeks from baseline
BMI
Time frame: 12 weeks from baseline
Android/Gynoid Fat Ratio
Time frame: 12 weeks from baseline
Muscle Mass (g)
Time frame: 12 weeks from baseline
Muscle Mass (Percentage of Body Weight)
Time frame: 12 weeks from baseline
Waist Circumference
Time frame: Baseline, 6 weeks and 12 weeks
Hip Circumference
Time frame: Baseline, 6 weeks and 12 weeks
Waist/Hip Circumference Ratio
Time frame: Baseline, 6 weeks and 12 weeks
Microbiota Analysis: Shannon Index
Time frame: 12 weeks from baseline
Microbiota Analysis: Chao1 Index
Time frame: 12 weeks from baseline
Microbiota Analysis: Evenness Index
Time frame: 12 weeks from baseline
Microbiota Analysis: Observed ASV Index
Time frame: 12 weeks from baseline
Microbiota Analysis: Faith's PD Index
Time frame: 12 weeks from baseline
Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0
Time frame: 12 weeks from baseline
Total Cholesterol
Time frame: Baseline and 12 weeks of supplementation
HDL-cholesterol
Time frame: Baseline and 12 weeks of supplementation
LDL-cholesterol
Time frame: Baseline and 12 weeks of supplementation
Triglycerides
Time frame: Baseline and 12 weeks of supplementation
Fasting Blood Glucose
Time frame: Baseline and 12 weeks of supplementation
HbA1c
Time frame: Baseline and 12 weeks of supplementation
Fasting Insulin
Time frame: Baseline and 12 weeks of supplementation
Alkaline Phosphatase (ALP)
Time frame: Baseline and 12 weeks of supplementation
Gamma-glutamyl Transferase (GGT)
Time frame: Baseline and 12 weeks of supplementation
Alanine Aminotransferase (ALT)
Time frame: Baseline and 12 weeks of supplementation
Aspartate Transaminase (AST)
Time frame: Baseline and 12 weeks of supplementation
Frequency of Bowel Movements
Time frame: Baseline, 6 and 12 weeks of supplementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. breve strain in people with Obesity and Overweight and Obesity, run by Morinaga Milk Industry Co., LTD at 1 site in Canada.
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 17 inclusion and 54 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 20 Oct 2025. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Fat Loss (g) (time frame: 12 weeks from baseline). The study lists 2 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 20 Oct 2025.