Cognitive ChangeShotRMNCT05323825
Effect of a Fermented Dairy Food With Probiotics on Mental Performance
A study testing Probiotic in people with Cognitive Change, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2022to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Fermented milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Fermented milk product containing a probiotic
PlaceboDietary supplement
Product with identical characteristics to the experimental product.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The content of the package is 100 g and should be consumed once a day for 8 weeks. Receives: Dietary Supplement: Probiotic |
| Control group | Placebo comparator | The content of the package is 100 g and should be consumed once a day for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
COMPASS cognitive test panel
Measured: Change in baseline cognitive performance after 8 weeks of consumption
Secondary outcomes (13)
Perceived Stress Scale
PSS-14 test
Measured: Day 1, at 4 and 8 weeks later
Mood profile
POMS test
Measured: Day 1, at 4 and 8 weeks later
Depression, Anxiety and Stress
DASS21 test
Measured: Day 1, at 4 and 8 weeks later
State of mind
PANAS test
Measured: Day 1, at 4 and 8 weeks later
Stress status using VAS scale
Stress status on the day of the visit
Measured: Day 1, at 4 and 8 weeks later
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Measured: 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
Measured: Day 1, at 4 and 8 weeks later
Gut microbiota
Evaluated with stool sample
Measured: 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.
Measured: 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.
Measured: Day 1, at 4, 8 and 12 weeks later
Dietary survey
Three days will be evaluated (two weekdays and one weekend day).
Measured: Day 1, at 4, 8 and 12 weeks later
Body weight
Bioimpedance, in Kg. For this we will use a TANITA
Measured: 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)
Measured: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start25 Apr 2022
- Primary completion16 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
- Investigators
- Fco Javier López Román, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323825
- Sponsor's protocol ID
- UCAMCFE-00026
- Acronym
- ShotRM
- Status last verified
- Mar 2022
- First submitted
- 26 Mar 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance
- ClinicalTrials.gov ID
- NCT05323825
- Acronym / sponsor ID
- ShotRM / UCAMCFE-00026
- Conditions
- Cognitive Change
- Keywords
- Probiotic, Fermented milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: ProbioticThe content of the package is 100 g and should be consumed once a day for 8 weeks. |
| Control group | Placebo comparator | Dietary Supplement: PlaceboThe content of the package is 100 g and should be consumed once a day for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticFermented milk product containing a probiotic | Dietary supplement | Experimental group |
| PlaceboProduct with identical characteristics to the experimental product. | Dietary supplement | Control group |
Primary outcome
Cognitive performance
Time frame: Change in baseline cognitive performance after 8 weeks of consumption
COMPASS cognitive test panel
13 secondary outcomes
Perceived Stress Scale
Time frame: Day 1, at 4 and 8 weeks later
Mood profile
Time frame: Day 1, at 4 and 8 weeks later
Depression, Anxiety and Stress
Time frame: Day 1, at 4 and 8 weeks later
State of mind
Time frame: Day 1, at 4 and 8 weeks later
Stress status using VAS scale
Time frame: Day 1, at 4 and 8 weeks later
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).
Sleep quality
Time frame: Day 1, at 4 and 8 weeks later
Gut microbiota
Time frame: Day 1, at 4, 8 and 12 weeks later
Adverse events
Time frame: At 4 weeks, 8 and 12 weeks after consumption
Concomitant medication
Time frame: Day 1, at 4, 8 and 12 weeks later
Dietary survey
Time frame: Day 1, at 4, 8 and 12 weeks later
Body weight
Time frame: Day 1, at 8 weeks later
Liver safety variables
Time frame: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fco Javier López Román principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Cognitive Change, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance (time frame: Change in baseline cognitive performance after 8 weeks of consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.