Clinical trial NCT05440630: Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: Nois de México
First posted: 2022-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in abdominal/visceral fat area
timeFrame: 0 week to 16 week
Secondary outcomes:
measure: Change in abdominal subcutaneous fat area
timeFrame: 0 week to 16 week
measure: Change in body composition
timeFrame: 0 week to 16 week
measure: Change in body weight
timeFrame: week 0, week 4, week 8, week 16
measure: Change in BMI
timeFrame: week 0, week 4, week 8, week 16
measure: Change in waist circumference
timeFrame: week 0, week 4, week 8, week 16
measure: Change in hip circumference
timeFrame: week 0, week 4, week 8, week 16
measure: Change in lipid profile
timeFrame: week 0, week 16
measure: Change in systolic and diastolic blood pressure
timeFrame: week 0, week 4, week 8, week 16
measure: Changes in glucose profile
timeFrame: week 0, week 16
measure: Change in cortisol levels
timeFrame: week 0, week 16
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Nois de Mexico S.A. de C.V.
Study officials:
affiliation: NOIS DE MEXICO S.A. DE C.V.
name: Joshue Covarrubia Esquer, Dr
role: PRINCIPAL_INVESTIGATOR
References: