Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults

NCT04677738 | Completed Results

• 1 other identifier: 20BWHM
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.

Conditions

Obesity; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 weeks from baseline

Secondary Outcomes (39)

• Body Weight

  12 weeks from baseline

• BMI

  12 weeks from baseline

• Android/Gynoid Fat Ratio

  12 weeks from baseline

• Muscle Mass (g)

  12 weeks from baseline

• Muscle Mass (Percentage of Body Weight)

  12 weeks from baseline

Study Arms (2)

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.

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.

Dietary Supplement: B. breve strain

Interventions

B. breve strain DIETARY_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.

B. breve

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Morinaga Milk Industry Co., LTD: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc

London, Ontario, N6A 5RB, Canada

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

none applicable

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Morinaga Milk Industry Co., Ltd.

izen-ri138@morinagamilk.co.jp

+81-46-252-3067

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: December 21, 2020
• Study Start: August 20, 2020
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: October 20, 2025
• Results First Posted: March 6, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)