Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals (KOBI)

The Archer-Daniels-Midland Company

Status: Enrolling

Conditions: Abdominal Obesity; Obesity

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Postbiotic; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05428137

PCTB202014

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Postbiotic

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Postbiotic

Placebo

Placebo Comparator group

Description:

Placebo in a form of a capsule administered for 16 weeks

Treatment:

Other: Placebo