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

Last updated: March 4, 2024
Sponsor: The Archer-Daniels-Midland Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

Probiotic

Postbiotic

Placebo

Clinical Study ID

NCT05428137
PCTB202014
  • Ages 19-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index 25-33kg/m2
  • Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
  • written informed consent

Exclusion

Exclusion Criteria:

  • Taking the following medication within 1 month before starting the study: appetitestimulants/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 participationnot in the best interest of the patient or could prevent, limit or confound theStudy's results

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Probiotic
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The Catholic University of Korea St. Vincent's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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