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Completed

NCT Number: NCT05323825

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.

Completed

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

Fermented milk product containing a probiotic

Placebo

Dietary Supplement

Product with identical characteristics to the experimental product.

Primary outcomes

  1. Cognitive performance

    Time frame: Change in baseline cognitive performance after 8 weeks of consumption

    COMPASS cognitive test panel

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: Day 1, at 4 and 8 weeks later

    PSS-14 test

  2. Mood profile

    Time frame: Day 1, at 4 and 8 weeks later

    POMS test

  3. Depression, Anxiety and Stress

    Time frame: Day 1, at 4 and 8 weeks later

    DASS21 test

  4. State of mind

    Time frame: Day 1, at 4 and 8 weeks later

    PANAS test

  5. Stress status using VAS scale

    Time frame: Day 1, at 4 and 8 weeks later

    Stress status on the day of the visit

  6. Sleep efficiency

    Time frame: 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).

    Measured by accelerometry, with Actigraph wGT3X-BT

  7. Sleep quality

    Time frame: Day 1, at 4 and 8 weeks later

    Pittsburgh test

  8. Gut microbiota

    Time frame: Day 1, at 4, 8 and 12 weeks later

    Evaluated with stool sample

  9. Adverse events

    Time frame: At 4 weeks, 8 and 12 weeks after consumption

    It will be evaluated at each of the visits and in the month of follow-up will be evaluated with a daily diary.

  10. Concomitant medication

    Time frame: Day 1, at 4, 8 and 12 weeks later

    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.

  11. Dietary survey

    Time frame: Day 1, at 4, 8 and 12 weeks later

    Three days will be evaluated (two weekdays and one weekend day).

  12. Body weight

    Time frame: Day 1, at 8 weeks later

    Bioimpedance, in Kg. For this we will use a TANITA

  13. Liver safety variables

    Time frame: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.

    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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: ShotRM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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