Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals (Obelix)

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

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Postbiotic; Dietary supplement: Placebo

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guadalajara, Mexico, 45050
    • Nois de Mexico S.A. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 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; 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.
Experimental: 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.	Dietary supplement: Postbiotic; 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.
Placebo Comparator: Placebo; Participants in this arm will receive an equivalent placebo for 16 weeks.	Dietary supplement: Placebo; Participants in this arm will receive an equivalent placebo for 16 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: Nois de México
• Investigators: Principal Investigator: Joshue Covarrubia Esquer, Dr, Nois de Mexico S.A. de C.V.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: PCTB202015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No