Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals (Obelix)

The Archer-Daniels-Midland Company

Status: Not yet enrolling

Conditions: Obesity

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Postbiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05440630

PCTB202015

Details and patient eligibility

About

The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.

Full description

Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Male and female subjects from 18 to 65 years old.

Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)

Waist circumference ≥ 102 cm for men

Waist circumference ≥ 88 cm for women

Signature of the informed consent letter.

Agreement to comply with the protocol and study restrictions

Exclusion criteria

Diagnosed and pharmacologically-treated type 1 or type 2 diabetes

Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease

Immunosuppression or ongoing therapy causing immunosuppression

Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia

Subjects consuming antibiotics in the previous 2 months

Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.

History of chronic active inflammatory disorders

History of bariatric surgery

History of any chronic gastrointestinal disease (e.g. IBD).

Known hypersensitivity to any ingredients in the active or placebo products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.

Treatment:

Dietary Supplement: Probiotics

Postbiotic

Experimental group

Description:

Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks.

Treatment:

Dietary Supplement: Postbiotic

Placebo

Placebo Comparator group

Description:

Participants in this arm will receive an equivalent placebo for 16 weeks.

Treatment:

Dietary Supplement: Placebo