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Probiotic
Bifidobacterium breve for Fat Loss
N/A
Waitlist Available
Led By David Crowley, MD
Research Sponsored by Morinaga Milk Industry Co., LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks and 12 weeks
Awards & highlights
Study Summary
This trial investigates whether a supplement called Bifidobacterium breve, combined with exercise, can help people lose fat.
Who is the study for?
Adults aged 20-65 with a BMI of 25.0 to 29.9, not pregnant or planning pregnancy, and using reliable birth control can join this trial. They must have stable weight for the past three months, agree to diet and exercise guidelines, and provide stool samples. Excluded are those with certain mental conditions, diabetes, sleep apnea, recent heart events or surgeries, HIV/Hepatitis B/C positive status; on medications affecting weight or blood clotting; substance abuse issues; unstable diseases.Check my eligibility
What is being tested?
This study tests whether taking Bifidobacterium breve supplements along with an exercise program helps healthy adults lose fat compared to a placebo group that doesn't receive the supplement but follows the same exercise routine.See study design
What are the potential side effects?
Potential side effects from Bifidobacterium breve supplementation may include digestive discomfort such as gas or bloating since it's a probiotic aimed at altering gut bacteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fat loss
Secondary outcome measures
Alanine aminotransferase (ALT)
Alkaline phosphatase (ALP)
Android/gynoid fat ratio
+18 moreOther outcome measures
Basophil count
Blood pressure (BP)
Body temperature
+40 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: B. breveExperimental Treatment1 Intervention
Capsule containing B breve. 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 B-3 in the morning before breakfast for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B. breve
2020
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
Morinaga Milk Industry Co., LTDLead Sponsor
4 Previous Clinical Trials
796 Total Patients Enrolled
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,065 Total Patients Enrolled
1 Trials studying Obesity
14 Patients Enrolled for Obesity
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,658 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mental or neurological condition that may affect your ability to take part in the study, according to the opinion of the person in charge.You have reported having trouble breathing while sleeping.Your body mass index (BMI) falls between 25.0 and 29.9 kg/m2.You have a sleep schedule that is not consistent or regular.You are allergic or have a bad reaction to any of the ingredients in the study drug.You have a condition that weakens your immune system or an autoimmune disease.You have ongoing problems with diarrhea or constipation that have lasted for a long time.You have ongoing health problems that are not well controlled or stable.You have a history of or currently have kidney and/or liver diseases, unless you only had kidney stones and have been symptom-free for 6 months.You have any type of cancer, except for skin cancer that has been completely removed without needing chemotherapy or radiation. If your cancer has been in remission for more than five years, you can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: B. breve
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the population participating in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this trial initiated on August 30th 2020 and is actively looking for participants with the goal of securing 100 people from a single site."
Answered by AI
May I be included in this research endeavor?
"The researchers of this trial are seeking 100 obese individuals between the ages 20 and 65. Mandatory criteria for applicants include: using hormonal contraceptives, having a BMI ranging from 25 - 29.9 kg/m2, being post-menopausal (for at least one year) or sterilized if female; non-heterosexual lifestyle or willing to use contraception when changing partners if planning on switching to heterosexual partnership; self-reported stable body weight over the past 3 months which cannot have changed by more than 5kg since baseline measurements were taken."
Answered by AI
Is this study still recruiting participants?
"According to records on clinicaltrials.gov, this experiment is still in its recruitment phase and has been since August 30th 2020. The most recent update was made on October 18th 2021."
Answered by AI
Does this investigation allow applicants over the age of 20 to participate?
"According to the trial's enrolment criteria, participants must be somewhere between 20 and 65 years old. For those younger than 18 or older than 65 there are 223 studies and 698 studies respectively."
Answered by AI
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