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

Prior treatment

• Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
• Participants with hyperlipidemia and are on medication
• 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
• 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
• Self-reported alcohol or drug abuse within the last 12 months
• 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

Other illness

• Current or history of any significant gastrointestinal disease requiring medication (e.g. GERD, gastroenteritis)
• Participants with hypertension and are on antihypertensive medication
• Type I or Type II diabetes
• 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
• 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
• Self-reported mental or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
• 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
• 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

Lab values

• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Blood/bleeding disorders as determined by laboratory results

Other

• Women who are pregnant, breastfeeding or planning to become pregnant during the trial
• Irregular sleep schedule
• Chronic diarrhea or constipation
• Self-reported sleep apnea
• Use of tobacco products within 60 days of baseline
• 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
• Individuals who are unable to give informed consent

• 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)