The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
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.
Participants in this arm will receive an equivalent placebo for 16 weeks.
Nois de Mexico S.A. de C.V.
Guadalajara, Mexico
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.
Time frame: 0 week to 16 week
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.
Time frame: 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).
Time frame: 0 week to 16 week
Change in body weight
Body weight change (percent and kg) at all visits - difference within and between groups.
Time frame: week 0, week 4, week 8, week 16
Change in BMI
BMI change (units and percent) at all visits - difference within and between groups.
Time frame: week 0, week 4, week 8, week 16
Change in waist circumference
Change in waist circumference (all visits V1-4)
Time frame: 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)
Time frame: week 0, week 4, week 8, week 16
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Change in lipid profile
Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months)
Time frame: week 0, week 16
Change in systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure (mmHg)
Time frame: 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)
Time frame: week 0, week 16
Change in cortisol levels
Change in cortisol levels (nmol/L)
Time frame: week 0, week 16