Obesity
Conditions
Brief summary
The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
Detailed description
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
Interventions
DIETARY_SUPPLEMENTProbiotics
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_SUPPLEMENTPostbiotic
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.
DIETARY_SUPPLEMENTPlacebo
Participants in this arm will receive an equivalent placebo for 16 weeks.
Sponsors
Nois de México
The Archer-Daniels-Midland Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal/visceral fat area | 0 week to 16 week | Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition | 0 week to 16 week | 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). |
| Change in body weight | week 0, week 4, week 8, week 16 | Body weight change (percent and kg) at all visits - difference within and between groups. |
| Change in BMI | week 0, week 4, week 8, week 16 | BMI change (units and percent) at all visits - difference within and between groups. |
| Change in waist circumference | week 0, week 4, week 8, week 16 | Change in waist circumference (all visits V1-4) |
| Change in abdominal subcutaneous fat area | 0 week to 16 week | Difference in abdominal subcutaneous fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. |
| Change in lipid profile | week 0, week 16 | Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months) |
| Change in systolic and diastolic blood pressure | week 0, week 4, week 8, week 16 | Change in systolic and diastolic blood pressure (mmHg) |
| Changes in glucose profile | week 0, week 16 | Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5) |
| Change in cortisol levels | week 0, week 16 | Change in cortisol levels (nmol/L) |
| Change in hip circumference | week 0, week 4, week 8, week 16 | Change in hip circumference at all visits difference within and between groups (absolute and relative) |
Countries
Mexico
Outcome results
None listed