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

Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Abdominal Obesity
• Intervention / Treatment: Other: Placebo; Dietary supplement: Probiotic; Dietary supplement: Postbiotic

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vineetha Vijayakumar, PhD; Phone Number: 07885966211; Email: vineetha.vijayakumar@adm.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University Of Korea St. Vincent's Hospital
    • Contact: MI KYUNG KIM, Dr
    • Principal Investigator: Song Sang-wook, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo in a form of a capsule administered for 16 weeks	Other: Placebo; Placebo in a form of a capsule given for 16 weeks
Active Comparator: Probiotic; Live bacteria strain in a form of a capsule daily for 16 weeks	Dietary supplement: Probiotic; Live bacteria strain in a form of a capsule daily for 16 weeks
Active Comparator: Postbiotic; Heat treated bacteria strain in a form of a capsule daily for 16 weeks	Dietary supplement: Postbiotic; Heat treated bacteria strain in a form of a capsule daily for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Body weight (kg) will be assessed at week 0, Week 12, Week 16	Week 0, Week 12, Week 16
Change in waist circumference	Change in waist circumference (cm) at week 0, week 12 and week 16	Week 0, Week 12, 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	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	Week 0, Week 16
Change in serum insulin concentration	Change in serum insulin from week 0 to week 16	Week 0, Week 16
Change in peripheral blood glucose	Change in blood glucose from week 0 to week 16	Week 0, Week 16
Change in plasma leptin levels	Change in leptin week 0 to week 16	Week 0, 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.	Week 0, Week 16
Microbiome analysis	Stool samples will be collected from participants to analyse change in intestinal microbiota community composition by 16SRNA sequencing	Week 0, Week 16
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.	Week 0, Week 16

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Investigators: Study Chair: Daniel Ramon Vidal, ADM Biopolis

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Obesity, Abdominal
• Other Study ID Numbers: PCTB202014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No