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

Primary Purpose

Obesity

Status

Not yet recruiting

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Probiotics

Postbiotic

Placebo

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Nois de Mexico S.A. de C.V.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Postbiotic

Placebo

Arm Description

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 probiotic (Heat treated bacteria) for 16 weeks.

Participants in this arm will receive an equivalent placebo for 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Change in body weight

Body weight change (percent and kg) at all visits - difference within and between groups.

Change in BMI

BMI change (units and percent) at all visits - difference within and between groups.

Change in waist circumference

Change in waist circumference (all visits V1-4)

Change in hip circumference

Change in hip circumference at all visits difference within and between groups (absolute and relative)

Change in lipid profile

Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months)

Change in systolic and diastolic blood pressure

Change in systolic and diastolic blood pressure (mmHg)

Changes in glucose profile

Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5)

Change in cortisol levels

Change in cortisol levels (nmol/L)

Full Information

NCT ID

NCT05440630

First Posted

June 16, 2022

Last Updated

June 27, 2022

Sponsor

The Archer-Daniels-Midland Company

Collaborators

Nois de México

1. Study Identification

Unique Protocol Identification Number

NCT05440630

Brief Title

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

Acronym

Obelix

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Archer-Daniels-Midland Company

Collaborators

Nois de México

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

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.

Arm Title

Postbiotic

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants in this arm will receive an equivalent placebo for 16 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotics

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Postbiotic

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Participants in this arm will receive an equivalent placebo for 16 weeks.

Primary Outcome Measure Information:

Title

Change in abdominal/visceral fat area

Description

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

Secondary Outcome Measure Information:

Title

Change in abdominal subcutaneous fat area

Description

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

Title

Change in body composition

Description

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

Title

Change in body weight

Description

Body weight change (percent and kg) at all visits - difference within and between groups.

Time Frame

week 0, week 4, week 8, week 16

Title

Change in BMI

Description

BMI change (units and percent) at all visits - difference within and between groups.

Time Frame

week 0, week 4, week 8, week 16

Title

Change in waist circumference

Description

Change in waist circumference (all visits V1-4)

Time Frame

week 0, week 4, week 8, week 16

Title

Change in hip circumference

Description

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

Title

Change in lipid profile

Description

Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months)

Time Frame

week 0, week 16

Title

Change in systolic and diastolic blood pressure

Description

Change in systolic and diastolic blood pressure (mmHg)

Time Frame

week 0, week 4, week 8, week 16

Title

Changes in glucose profile

Description

Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5)

Time Frame

week 0, week 16

Title

Change in cortisol levels

Description

Change in cortisol levels (nmol/L)

Time Frame

week 0, week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vineetha Vijayakumar, PhD

Phone

00447885 966 211

vineetha.vijayakumar@adm.com

First Name & Middle Initial & Last Name or Official Title & Degree

Krizstina Levai

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshue Covarrubia Esquer, Dr

Organizational Affiliation

NOIS DE MEXICO S.A. DE C.V.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nois de Mexico S.A. de C.V.

City

Guadalajara

ZIP/Postal Code

45050

Country

Mexico

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krisztina Levai

krisztale@yahoo.co.uk

12. IPD Sharing Statement

Plan to Share IPD

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

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