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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05440630
• Other study ID #: PCTB202015
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: June 2022
• Source: The Archer-Daniels-Midland Company
• Contact: Vineetha Vijayakumar, PhD
• Phone: 00447885 966 211
• Email: vineetha.vijayakumar[@]adm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
Mexico	Nois de Mexico S.A. de C.V.	Guadalajara

Sponsors (2)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company	Nois de México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in BMI	BMI change (units and percent) at all visits - difference within and between groups.	week 0, week 4, week 8, week 16
Secondary	Change in waist circumference	Change in waist circumference (all visits V1-4)	week 0, week 4, week 8, week 16
Secondary	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
Secondary	Change in lipid profile	Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months)	week 0, week 16
Secondary	Change in systolic and diastolic blood pressure	Change in systolic and diastolic blood pressure (mmHg)	week 0, week 4, week 8, week 16
Secondary	Changes in glucose profile	Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5)	week 0, week 16
Secondary	Change in cortisol levels	Change in cortisol levels (nmol/L)	week 0, week 16