Bifidobacterium breve for Fat Loss

Recruiting in Palo Alto (17 mi)

Overseen byDavid Crowley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Morinaga Milk Industry Co., LTD

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) falls between 25.0 and 29.9 kg/m2.

Male or female between 20 and 65 years of age, 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

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Exclusion 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.

Type I or Type II diabetes

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Treatment Details

Interventions

Bifidobacterium breve (Probiotic)
Exercise Intervention (Behavioural Intervention)

Trial OverviewThis 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: B. breveExperimental Treatment1 Intervention

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.

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.