Back to resultsStudy of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals (KOBI)
Primary Purpose
Obesity, Abdominal Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probiotic
Postbiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Body mass index 25-33kg/m2
- Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
- written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- The Catholic University of Korea St. Vincent's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Postbiotic
Placebo
Arm Description
Live bacteria strain in a form of a capsule with a daily dose of 1x10^10 Colony Forming Unit (CFU) per day for 16 weeks
Heat treated bacteria strain in a form of a capsule with a daily dose of 1x10^10 CFU per day for 16 weeks
Placebo in a form of a capsule administered for 16 weeks
Outcomes
Primary Outcome Measures
Change in visceral fat area
Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16
Secondary Outcome Measures
Change in body weight
Body weight (kg) will be assessed at week 0, Week 12, Week 16
Change in waist circumference
Change in waist circumference (cm) at week 0, week 12 and week 16
Change in body fat composition
Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16
Change in peripheral blood cholesterol
Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16
Change in serum insulin concentration
Change in serum insulin from week 0 to week 16
Change in peripheral blood glucose
Change in blood glucose from week 0 to week 16
Change in plasma leptin levels
Change in leptin week 0 to week 16
Dietary survey
Food cravings will be assessed using the Food Craving Questionnaires (FCQ) at week 0 and week 16. The change in score compared to baseline and between groups will be assessed at the end of the study.
Microbiome analysis
Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing
Mood questionnaire
Participants mood will be assessed using the PHQ-9 (Patient Health Questionnaire-9). The change in score compared to baseline and between groups will be assessed at the end of the study.
Full Information
NCT ID
NCT05428137
First Posted
May 24, 2022
Last Updated
July 20, 2023
Sponsor
The Archer-Daniels-Midland Company
1. Study Identification
Unique Protocol Identification Number
NCT05428137
Brief Title
Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
Acronym
KOBI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Archer-Daniels-Midland Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 arm parallel design
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Live bacteria strain in a form of a capsule with a daily dose of 1x10^10 Colony Forming Unit (CFU) per day for 16 weeks
Arm Title
Postbiotic
Arm Type
Active Comparator
Arm Description
Heat treated bacteria strain in a form of a capsule with a daily dose of 1x10^10 CFU per day for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in a form of a capsule administered for 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Live bacteria strain in a form of a capsule with a daily dose of 1x10^10 CFU per day for 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Postbiotic
Intervention Description
Heat treated bacteria strain in a form of a capsule with a daily dose of 1x10^10 CFU per day for 16 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo in a form of a capsule given for 16 weeks
Primary Outcome Measure Information:
Title
Change in visceral fat area
Description
Difference in visceral fat area (cm^2) measured using CT from week 0 to week 16
Time Frame
From week 0 to Week 16
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Body weight (kg) will be assessed at week 0, Week 12, Week 16
Time Frame
Week 0, Week 12, Week 16
Title
Change in waist circumference
Description
Change in waist circumference (cm) at week 0, week 12 and week 16
Time Frame
Week 0, Week 12, Week 16
Title
Change in body fat composition
Description
Change in body fat composition using dual-energy x-ray absorptiometry (DEXA) at week 0, Week 12, Week 16
Time Frame
Week 0, Week 12, Week 16
Title
Change in peripheral blood cholesterol
Description
Change in Cholesterol concentration (mg/dL) (total, HDL, LDL) in peripheral blood from week 0 to week 16
Time Frame
Week 0, Week 16
Title
Change in serum insulin concentration
Description
Change in serum insulin from week 0 to week 16
Time Frame
Week 0, Week 16
Title
Change in peripheral blood glucose
Description
Change in blood glucose from week 0 to week 16
Time Frame
Week 0, Week 16
Title
Change in plasma leptin levels
Description
Change in leptin week 0 to week 16
Time Frame
Week 0, Week 16
Title
Dietary survey
Description
Food cravings will be assessed using the Food Craving Questionnaires (FCQ) at week 0 and week 16. The change in score compared to baseline and between groups will be assessed at the end of the study.
Time Frame
Week 0, Week 16
Title
Microbiome analysis
Description
Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing
Time Frame
Week 0, Week 16
Title
Mood questionnaire
Description
Participants mood will be assessed using the PHQ-9 (Patient Health Questionnaire-9). The change in score compared to baseline and between groups will be assessed at the end of the study.
Time Frame
Week 0, Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index 25-33kg/m2
Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
written informed consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vineetha Vijayakumar, PhD
Phone
07885966211
Email
vineetha.vijayakumar@adm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ramon Vidal
Organizational Affiliation
ADM Biopolis
Official's Role
Study Chair
Facility Information:
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MI KYUNG KIM, Dr
First Name & Middle Initial & Last Name & Degree
Song Sang-wook, Doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals
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