Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
NCT ID: NCT05428137
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-07-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
Probiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
Postbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
Postbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
Placebo
Placebo in a form of a capsule administered for 16 weeks
Placebo
Placebo in a form of a capsule given for 16 weeks
Interventions
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Probiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
Postbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
Placebo
Placebo in a form of a capsule given for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm)
* written informed consent
Exclusion Criteria
* 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
19 Years
75 Years
ALL
Yes
Sponsors
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The Archer-Daniels-Midland Company
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Ramon Vidal
Role: STUDY_CHAIR
ADM Biopolis
Locations
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The Catholic University of Korea St. Vincent's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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MI KYUNG KIM, Dr
Role: primary
Other Identifiers
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PCTB202014
Identifier Type: -
Identifier Source: org_study_id
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