Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428137
• Other study ID #: PCTB202014
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: The Archer-Daniels-Midland Company
• Contact: Vineetha Vijayakumar, PhD
• Phone: 07885966211
• Email: vineetha.vijayakumar[@]adm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity
• Obesity, Abdominal
• Overweight

Intervention

Dietary Supplement:
• 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

Other:
• Placebo
Placebo in a form of a capsule given for 16 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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