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

The Archer-Daniels-Midland Company180 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Obesity Abdominal Obesity

Interventions

ProbioticDIETARY_SUPPLEMENT

Live bacteria strain in a form of a capsule daily for 16 weeks

PostbioticDIETARY_SUPPLEMENT

Heat treated bacteria strain in a form of a capsule daily for 16 weeks

PlaceboOTHER

Placebo in a form of a capsule given for 16 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The Catholic University of Korea St. Vincent's Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change in visceral fat area

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 Outcomes

Change in body weight

Body weight (kg) will be assessed at week 0, Week 12, Week 16

Time frame: Week 0, Week 12, Week 16

Change in waist circumference

Change in waist circumference (cm) at week 0, week 12 and week 16

Time frame: 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

Time frame: 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

Time frame: Week 0, Week 16

Change in serum insulin concentration

Change in serum insulin from week 0 to week 16

Time frame: Week 0, Week 16

Change in peripheral blood glucose

Change in blood glucose from week 0 to week 16

Time frame: Week 0, Week 16

Change in plasma leptin levels

Change in leptin week 0 to week 16

Time frame: Week 0, Week 16

Central Contacts

Vineetha Vijayakumar, PhD

CONTACT

07885966211 vineetha.vijayakumar@adm.com

Data from ClinicalTrials.gov

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