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

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 th