Status:
WITHDRAWN
Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals
Lead Sponsor:
The Archer-Daniels-Midland Company
Collaborating Sponsors:
Nois de México
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05440630
Start Date
July 1 2022
End Date
October 30 2023
Last Update
March 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nois de Mexico S.A. de C.V.
Guadalajara, Mexico, 45050