Status:
RECRUITING
Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
Lead Sponsor:
The Archer-Daniels-Midland Company
Conditions:
Obesity
Abdominal Obesity
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Detailed Description
This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recru...
Eligibility Criteria
Inclusion
- Body mass index 25-33kg/m2
- Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm)
- written informed consent
Exclusion
- Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
- taking antibiotics within 2 months before starting the study
- secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
- consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
- nicotine, drug or alcohol abuse,
- other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05428137
Start Date
July 1 2022
End Date
December 1 2024
Last Update
March 5 2024
Active Locations (1)
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1
The Catholic University of Korea St. Vincent's Hospital
Seoul, South Korea