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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The content of the package is 100 g and should be consumed once a day for 8 weeks.	Dietary supplement: Probiotic; Fermented milk product containing a probiotic
Placebo Comparator: Control group; The content of the package is 100 g and should be consumed once a day for 8 weeks.	Dietary supplement: Placebo; Product with identical characteristics to the experimental product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	COMPASS cognitive test panel	Change in baseline cognitive performance after 8 weeks of consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	PSS-14 test	Day 1, at 4 and 8 weeks later
Mood profile	POMS test	Day 1, at 4 and 8 weeks later
Depression, Anxiety and Stress	DASS21 test	Day 1, at 4 and 8 weeks later
State of mind	PANAS test	Day 1, at 4 and 8 weeks later
Stress status using VAS scale	Stress status on the day of the visit	Day 1, at 4 and 8 weeks later
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).
Sleep quality	Pittsburgh test	Day 1, at 4 and 8 weeks later
Gut microbiota	Evaluated with stool sample	Day 1, at 4, 8 and 12 weeks later
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
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
Dietary survey	Three days will be evaluated (two weekdays and one weekend day).	Day 1, at 4, 8 and 12 weeks later
Body weight	Bioimpedance, in Kg. For this we will use a TANITA	Day 1, at 8 weeks later
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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Fco Javier López Román, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Probiotic; Fermented milk
• Other Study ID Numbers: UCAMCFE-00026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No