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

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