Effect of a Fermented Dairy Food With Probiotics on Mental Performance (ShotRM)

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Cognitive Change

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT05323825

UCAMCFE-00026

Details and patient eligibility

About

Single-center, randomized, double-blind, placebo-controlled clinical study with two study groups.

One group will consume a product with functional ingredients and the other group will consume a placebo product. will consume a placebo product.

Full description

When individuals are included in the study they will be randomized in equal proportion to one of the 2 groups of the study. The randomization will be stratified by age taking into account 2 strata (1:1). The first stratum corresponds to an age range of 18 to 40 years and the second stratum to an age range of 41 to 60 years.

The subject must consume the product for 8 weeks and will have a visit 4 weeks later as a follow-up of the study.

At the visits the subject will perform a series of cognitive tests and the intestinal microbiota will be evaluated.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women aged 18-60 years.
Individuals with a diagnosis of mild-moderate stress according to the Cohen's perceived stress scale perceived stress scale (PSS-10).
Subjects with poor adherence to the Mediterranean diet according to the PREDIMED questionnaire (value below 9 points)*.
BMI between 19 and 30 kg/m2.

Exclusion criteria

Present chronic and/or acute digestive pathologies that may interfere in the absorption of nutrients (inflammatory intestinal diseases, inflammatory bowel absorption of nutrients (inflammatory intestinal diseases, etc.), etc.)
Intake of probiotics and/or prebiotics in the four weeks prior to the inclusion in the study.
Individuals who are on antibiotic treatment or have completed an antibiotic treatment during the 30 days prior to inclusion in the study.
Vegan diet.
Being taking any type of supplementation that interacts with cognitive level in the 2 weeks prior to the start of the study.
Individuals who had taken or were taking any medications or supplementation for stress management, mood, or to induce sleep in the 2 weeks prior to the start of the study.
A history of allergic hypersensitivity or poor tolerance to any component of the products under study.
Consumption of 2 or more Standard Drink Units (UBE) daily or 17 weekly in women, or consume 4 or more UBE daily or 28 weekly in men.
Smoking and non-smoking subjects who have modified their nicotinic habits in the last 3 months.
Pregnant or lactating women.
Been participating or have participated in another clinical trial in the 2 months prior to the study to the study.
Unwillingness or inability to comply with the procedures of the clinical trial.
Subjects with any diagnosed psychiatric disorder.
Subjects whose condition makes them ineligible for the study in accordance with the criteria of the investigator.