Clinical trial NCT04677738: Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight and Obesity
Lead sponsor: Morinaga Milk Industry Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2020-12-21
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. 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)
  2. Double-barrier method
  3. Intrauterine devices
  4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
  5. 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):

  1. Female: ≥ 30%
  2. 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)

Exclusion Criteria

* 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
* 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:

  1. Beta-blockers and thiazide diuretics (within 4 weeks of baseline)
  2. Weight loss medication (within 4 weeks of baseline)
  3. Lipid-lowering medications (within 4 weeks of baseline)
  4. Anticoagulants and coagulants (within 4 weeks of baseline)
  5. Sleep medication
  6. Selective serotonin reuptake inhibitors (SSRI)
  7. Antibiotics
  8. Non-steroidal anti-inflammatory drugs (NSAIDs)
  9. Proton pump inhibitors (PPIs)
  10. 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:

  1. OTC NSAIDs (PRN use is acceptable)
  2. OTC blood pressure medication or supplements (within 4 weeks of
  3. baseline)
  4. Lipid metabolising supplements (within 4 weeks of baseline)
  5. Fish oil and omega-3 supplements
  6. Red yeast rice
  7. Plant sterols and stanols
  8. OTC medication or supplements marketed for weight loss (within 4 weeks
  9. of baseline)
  10. Vitamin E supplements (within 4 weeks of baseline)
  11. Coagulant/anticoagulant supplements (within 4 weeks of baseline)
  12. 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

Primary outcomes:
measure: Change in Fat Loss (g)
timeFrame: 12 weeks from baseline
measure: Change in Fat Loss (Percentage of Body Weight)
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Body Weight
timeFrame: 12 weeks from baseline
measure: BMI
timeFrame: 12 weeks from baseline
measure: Android/Gynoid Fat Ratio
timeFrame: 12 weeks from baseline
measure: Muscle Mass (g)
timeFrame: 12 weeks from baseline
measure: Muscle Mass (Percentage of Body Weight)
timeFrame: 12 weeks from baseline
measure: Waist Circumference
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Hip Circumference
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Waist/Hip Circumference Ratio
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Microbiota Analysis: Shannon Index
timeFrame: 12 weeks from baseline
measure: Microbiota Analysis: Chao1 Index
timeFrame: 12 weeks from baseline
measure: Microbiota Analysis: Evenness Index
timeFrame: 12 weeks from baseline
measure: Microbiota Analysis: Observed ASV Index
timeFrame: 12 weeks from baseline
measure: Microbiota Analysis: Faith's PD Index
timeFrame: 12 weeks from baseline
measure: Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0
timeFrame: 12 weeks from baseline
measure: Total Cholesterol
timeFrame: Baseline and 12 weeks of supplementation
measure: HDL-cholesterol
timeFrame: Baseline and 12 weeks of supplementation
measure: LDL-cholesterol
timeFrame: Baseline and 12 weeks of supplementation
measure: Triglycerides
timeFrame: Baseline and 12 weeks of supplementation
measure: Fasting Blood Glucose
timeFrame: Baseline and 12 weeks of supplementation
measure: HbA1c
timeFrame: Baseline and 12 weeks of supplementation
measure: Fasting Insulin
timeFrame: Baseline and 12 weeks of supplementation
measure: Alkaline Phosphatase (ALP)
timeFrame: Baseline and 12 weeks of supplementation
measure: Gamma-glutamyl Transferase (GGT)
timeFrame: Baseline and 12 weeks of supplementation
measure: Alanine Aminotransferase (ALT)
timeFrame: Baseline and 12 weeks of supplementation
measure: Aspartate Transaminase (AST)
timeFrame: Baseline and 12 weeks of supplementation
measure: Frequency of Bowel Movements
timeFrame: Baseline, 6 and 12 weeks of supplementation
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Inc
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: