Probiotics and Endotoxemia (PROMS-01)

Danisco

Status: Completed

Conditions: Metabolic Endotoxemia; Metabolic Syndrome

Treatments: Dietary Supplement: Probiotic bacterium Bifidobacterium lactis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176942

PROMS-01

Details and patient eligibility

About

The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index ≥ 27 kg/m2; above 18 years of age
• Used to eat high fat diet (more than 40% of total energy intake)

Exclusion criteria

• Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
• Severe illnesses
• Artificial heart valve
• Immunosuppression
• Regular consumption of probiotics
• History of bariatric surgery
• Consumption or wish to consume Orlistat
• Participation in other research
• Pregnancy or wishing/trying to get pregnant
• Inability to follow protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Treatment:

Dietary Supplement: Probiotic bacterium Bifidobacterium lactis

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Probiotic bacterium Bifidobacterium lactis