Clinical trial NCT05323825: Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Official title: Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: Probiotic
Fermented milk
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Cognitive performance
timeFrame: Change in baseline cognitive performance after 8 weeks of consumption
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Day 1, at 4 and 8 weeks later
measure: Mood profile
timeFrame: Day 1, at 4 and 8 weeks later
measure: Depression, Anxiety and Stress
timeFrame: Day 1, at 4 and 8 weeks later
measure: State of mind
timeFrame: Day 1, at 4 and 8 weeks later
measure: Stress status using VAS scale
timeFrame: Day 1, at 4 and 8 weeks later
measure: Sleep efficiency
timeFrame: It will be measured for 3 days, before starting the consumption of the product, after 30 days of consumption and at the end of consumption (60 days).
measure: Sleep quality
timeFrame: Day 1, at 4 and 8 weeks later
measure: Gut microbiota
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Adverse events
timeFrame: At 4 weeks, 8 and 12 weeks after consumption
measure: Concomitant medication
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Dietary survey
timeFrame: Day 1, at 4, 8 and 12 weeks later
measure: Body weight
timeFrame: Day 1, at 8 weeks later
measure: Liver safety variables
timeFrame: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Fco Javier López Román
role: PRINCIPAL_INVESTIGATOR
References: