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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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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:
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):
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:
Current use of over-the-counter medications, supplements, foods and/or drinks as follows:
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 purpose
Allocation
Interventional model
Masking
95 participants in 2 patient groups, including a placebo group
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Central trial contact
Andrew Charrette, MSc; Malkanthi Evans, PhD
Data sourced from clinicaltrials.gov
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