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

Not Applicable

Withdrawn

• Conditions: Obesity
• Interventions: Dietary Supplement: Postbiotic; Dietary Supplement: Placebo; Dietary Supplement: Probiotics

• Registration Number: NCT05440630
• Lead Sponsor: The Archer-Daniels-Midland Company

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.

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-27
• Study Start: 2022-07-01
• Study First Posted: 2022-07-01
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postbiotic	Postbiotic	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.
Placebo	Placebo	Participants in this arm will receive an equivalent placebo for 16 weeks.
Probiotic	Probiotics	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Change in cortisol levels	week 0, week 16	Change in cortisol levels (nmol/L)
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.
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 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 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)
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)

Trial Locations

Locations (1)

Nois de Mexico S.A. de C.V.; 🇲🇽 Guadalajara, Mexico