Status:
COMPLETED
Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults
Lead Sponsor:
Morinaga Milk Industry Co., LTD
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Obesity
Overweight and Obesity
Eligibility:
All Genders
20-65 years
Phase:
NA
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 associat...
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 i...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04677738
Start Date
August 20 2020
End Date
January 5 2024
Last Update
October 17 2025
Active Locations (1)
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1
KGK Science Inc
London, Ontario, Canada, N6A 5RB