Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
KOBI
Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
1 other identifier
interventional
180
1 country
1
Brief Summary
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2022
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 5, 2024
March 1, 2024
2.4 years
May 24, 2022
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in visceral fat area
Difference in visceral fat area (cm\^2) measured using CT from week 0 to week 16
From week 0 to Week 16
Secondary Outcomes (10)
Change in body weight
Week 0, Week 12, Week 16
Change in waist circumference
Week 0, Week 12, Week 16
Change in body fat composition
Week 0, Week 12, Week 16
Change in peripheral blood cholesterol
Week 0, Week 16
Change in serum insulin concentration
Week 0, Week 16
- +5 more secondary outcomes
Study Arms (3)
Probiotic
ACTIVE COMPARATORLive bacteria strain in a form of a capsule daily for 16 weeks
Postbiotic
ACTIVE COMPARATORHeat treated bacteria strain in a form of a capsule daily for 16 weeks
Placebo
PLACEBO COMPARATORPlacebo in a form of a capsule administered for 16 weeks
Interventions
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
Eligibility Criteria
You may qualify if:
- Body mass index 25-33kg/m2
- Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm)
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea St. Vincent's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel Ramon Vidal
ADM Biopolis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 22, 2022
Study Start
July 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
March 5, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share