Effect of a Fermented Dairy Food With Probiotics on Mental Performance

NCT ID: NCT05323825

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2023-01-25

Brief Summary

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.

Detailed 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.

Conditions

Cognitive Change

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

The content of the package is 100 g and should be consumed once a day for 8 weeks.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Fermented milk product containing a probiotic

Control group

The content of the package is 100 g and should be consumed once a day for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product.

Interventions

Probiotic

Fermented milk product containing a probiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Product with identical characteristics to the experimental product.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fco Javier López Román

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Murcia

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00026

Identifier Type: -

Identifier Source: org_study_id