Effect of a Fermented Dairy Food With Probiotics on Mental Performance

Cognitive Change Clinical Trial

— ShotRM  

Official title:

Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323825
• Other study ID #: UCAMCFE-00026
• Status: Completed
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: January 25, 2023

Study information

• Verified date: March 2022
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 25, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Dietary Supplement:
• Probiotic
Fermented milk product containing a probiotic
• Placebo
Product with identical characteristics to the experimental product.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance	COMPASS cognitive test panel	Change in baseline cognitive performance after 8 weeks of consumption
Secondary	Perceived Stress Scale	PSS-14 test	Day 1, at 4 and 8 weeks later
Secondary	Mood profile	POMS test	Day 1, at 4 and 8 weeks later
Secondary	Depression, Anxiety and Stress	DASS21 test	Day 1, at 4 and 8 weeks later
Secondary	State of mind	PANAS test	Day 1, at 4 and 8 weeks later
Secondary	Stress status using VAS scale	Stress status on the day of the visit	Day 1, at 4 and 8 weeks later
Secondary	Sleep efficiency	Measured by accelerometry, with Actigraph wGT3X-BT	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).
Secondary	Sleep quality	Pittsburgh test	Day 1, at 4 and 8 weeks later
Secondary	Gut microbiota	Evaluated with stool sample	Day 1, at 4, 8 and 12 weeks later
Secondary	Adverse events	It will be evaluated at each of the visits and in the month of follow-up will be evaluated with a daily diary.	At 4 weeks, 8 and 12 weeks after consumption
Secondary	Concomitant medication	The change in the use of medications will be evaluated. It will be evaluated at each of the visits and in the month of follow-up will be evaluated with a daily diary.	Day 1, at 4, 8 and 12 weeks later
Secondary	Dietary survey	Three days will be evaluated (two weekdays and one weekend day).	Day 1, at 4, 8 and 12 weeks later
Secondary	Body weight	Bioimpedance, in Kg. For this we will use a TANITA	Day 1, at 8 weeks later
Secondary	Liver safety variables	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)	It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.