Status:
COMPLETED
Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Cognitive Change
Eligibility:
All Genders
18-60 years
Phase:
NA
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 place...
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:...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05323825
Start Date
April 25 2022
End Date
January 25 2023
Last Update
June 18 2023
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107