Effect of Study Probiotics on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)

Official Title
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The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention: A Randomized, Double-blind, Placebo-controlled, Multi-center Study

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Daily intake of study product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary, written, signed, informed consent to participate in the study Male or female, age between 20 to 65 (inclusive) BMI between 28.0 and 34.9 (inclusive), of which 1:1 overweight (28.0-29.9):obese (30-34.9) Waist circumference for men of > 102 cm or for women of > 88 cm Agreement to comply with the protocol and study restrictions Access to Internet in addition to willingness and ability to use web-based questionnaires Available for all study visits Females of child-bearing potential required to provide a negative urine pregnancy test and agree to use a medically-approved method of birth control, eg. all of the following are approved: birth control pill, patch, shot, vaginal ring, mini pill, long-acting reversible contraception (LARC) meaning hormonal intrauterine device, nonhormonal intrauterine device with copper, subdermal contraceptive implant, condoms, cervical cap, diaphragm. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Exclusion Criteria: Diagnosed and pharmacologically-treated type 1 and type 2 diabetes (fasting blood glucose ≥ 7 mmol/l) Use of medication/supplements for blood glucose control Pharmacologically-treated (medication/supplements) hypertension or dyslipidemia Cardiovascular disease, hypertensive retinopathy, left ventricular dysfunction, secondary hypertension, liver dysfunction/disease, kidney dysfunction/disease, dementia, thyroid disease, pancreatic disease, history of cancer within past 5 years (excluding basal cell carcinoma), anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject Use of drugs or supplements to manage body weight or body fat in the last 3 months Use of laxatives or fiber supplements in the past 6 weeks. History of chronic active inflammatory disorders History of bariatric surgery History of any chronic gastrointestinal disease (e.g. IBD) or disorders (e.g. IBS, constipation, diarrhea), or gastrointestinal reflux disease Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs Regular (more than once per week) use of proton pump inhibitors Recent (last 3 months) or ongoing antibiotic use Immunosuppression or ongoing therapy causing immunosuppression Use of probiotic supplements during the previous 6 weeks Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past 3 months or planned cessation of the use of these products during the trial Use of vitamin D supplementation of ≥100 µg/day Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise) Weight change (increase or loss) of 3 kg during the past 3 months Pregnant or planning pregnancy during the study or breastfeeding Participation in a clinical trial with an investigational product or drug within 60 days prior to screening Likeliness to be noncompliant with the protocol No possibility of contact in case of emergency Illicit drug users Alcohol abusers Administrative or legal supervision Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Active<br>Bifidobacterium animalis ssp. lactis 420 at 1*10^10 colony forming units (CFU) per day | Dietary Supplement: Daily intake of study product<br>* Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period<br>|
| Placebo Comparator: Group Placebo<br>Placebo | Dietary Supplement: Daily intake of study product<br>* Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body fat mass relative change | Difference in total body fat mass relative change from baseline (Visit 2) to 6 months of product intake (Visit 5) between the active vs. placebo group | Change from baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk fat mass change | Change in trunk fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline at 2 months, 4 months and 6 months | 
| Waist circumference change | Change in waist circumference from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Android fat mass change | Change in android fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Lean body mass change | Change in lean body mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Energy intake change | Change in energy intake from baseline (Visit 2) to 6 months (Visit 5) | Change from baseline at 6 months | 
| Fat mass change in individual body regions | Change in fat mass in other individual body regions from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Total fat mass absolute change | Change in total body fat mass absolute change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Body weight change | Change in body weight from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| BMI change | Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative) | Change from baseline at 6 months | 
| Hip circumference change | Change in hip circumference from baseline (Visit 2) to, 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative) | Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) | 
| Total fat mass relative change | Change in total body fat mass relative change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4) | Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity