Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals

Study Overview
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Brief Summary
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The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.

Detailed Description
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Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.

Official Title
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Efficacy and Safety of Probiotic Strain Bifidobacterium Animalis Subsp. Lactis CECT 8145 Probiotic in the Reduction of Abdominal/Visceral Fat in Overweight and Obese Patients: Double-blind, Randomised, Placebo-controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Postbiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects from 18 to 65 years old. Established diagnosis of overweight (BMI ≥ 25 and up to 34.9) Waist circumference ≥ 102 cm for men Waist circumference ≥ 88 cm for women Signature of the informed consent letter. Agreement to comply with the protocol and study restrictions Exclusion Criteria: Diagnosed and pharmacologically-treated type 1 or type 2 diabetes Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease Immunosuppression or ongoing therapy causing immunosuppression Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia Subjects consuming antibiotics in the previous 2 months Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period. History of chronic active inflammatory disorders History of bariatric surgery History of any chronic gastrointestinal disease (e.g. IBD). Known hypersensitivity to any ingredients in the active or placebo products.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. | Dietary Supplement: Probiotics<br>* Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.<br>|
| Experimental: Postbiotic<br>Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks. | Dietary Supplement: Postbiotic<br>* Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks.<br>|
| Placebo Comparator: Placebo<br>Participants in this arm will receive an equivalent placebo for 16 weeks. | Dietary Supplement: Placebo<br>* Participants in this arm will receive an equivalent placebo for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal/visceral fat area | Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. | 0 week to 16 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal subcutaneous fat area | Difference in abdominal subcutaneous fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. | 0 week to 16 week | 
| Change in body composition | Difference in total body fat mass (kg) from baseline to 4 months of product intake within and between groups (relative and absolute, measured by bioelectrical impedance at V1 and V4). | 0 week to 16 week | 
| Change in body weight | Body weight change (percent and kg) at all visits - difference within and between groups. | week 0, week 4, week 8, week 16 | 
| Change in BMI | BMI change (units and percent) at all visits - difference within and between groups. | week 0, week 4, week 8, week 16 | 
| Change in waist circumference | Change in waist circumference (all visits V1-4) | week 0, week 4, week 8, week 16 | 
| Change in hip circumference | Change in hip circumference at all visits difference within and between groups (absolute and relative) | week 0, week 4, week 8, week 16 | 
| Change in lipid profile | Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months) | week 0, week 16 | 
| Change in systolic and diastolic blood pressure | Change in systolic and diastolic blood pressure (mmHg) | week 0, week 4, week 8, week 16 | 
| Changes in glucose profile | Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5) | week 0, week 16 | 
| Change in cortisol levels | Change in cortisol levels (nmol/L) | week 0, week 16 |