Cognitive PerformanceNCT07438236
Cognitive Performance and Mood After Ingestion of Dietary Supplement by University Students
A study testing Dietary Supplement in people with Cognitive Performance and Mood, run by Cooperativa de Ensino Superior, Politécnico e Universitário at 1 site in Portugal.
Trial summary
This study investigates the effect of dietary supplementation on cognitive Performance and mood in university students over a 60-day period using a double-blind randomized controlled design. This study includes 75 participants, aged 18 or older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Mood, Dietary Supplement
- What is being tested?
- Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jan 2025to 31 Oct 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants aged ≥ 18 years;
- students enrolled in Higher Technical Professional Courses and Bachelor's Degree Programs at ESSVA-IPSNCESPU;
- informed consent signed by the participant.
Who cannot join
- participants with any type of disease diagnosed in the last 3 months, or recent use of specific supplementation for the cognitive component, were excluded to minimize biases that could influence the results.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde do Vale do Ave
Vila Nova de Famalicão, Braga District, 4760-409
About this study
Official title: Desempenho Cognitivo e Humor Após Ingestão de Suplemento Alimentar Por Estudantes do Ensino Superior
This study investigates the effect of dietary supplementation on cognitive Performance and mood in university students over a 60-day period using a double-blind randomized controlled design. This study includes 75 participants, aged 18 or older. Participants will be randomly assigned to group I (n=25; will receive the supplement one), group II (n=25; will receive the supplement two), and group III (n=25; control/placebo).
Assessments will be conducted before starting supplementation, 30 days after, and at the end of the intervention to determine the effect of the supplementation on cognitive performance and mood. The main outcomes include cognitive status and mood measured by Depression Anxiety Stress Scales - (DASS), Brief Symptom Inventory (BSI) and Self-efficacy scale in higher education. Adherence to supplementation and potential side effects will also be assessed.
Read more
Based on the data obtained at these three assessment points, it will be possible to qualitatively address the actual effect of supplements on students' cognitive performance.
In addition, the participants nutritional status will also be assessed using the Simplified Appetite Nutrition Questionnaire (SANQ) and their perception of it using the Visual Appetite Scale (VAS). Both measurements will take place before the start of supplementation and at the end of the intervention.
- Conditions
- Cognitive Performance, Mood, Dietary Supplement, Safety
- Being tested
- Dietary Supplement, Placebo
- Keywords
- Dietary Supplement, Mental Health, Cognitive Performance, Self-eficacy
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
Dietary Supplements Participants in this arm will receive a daily dose of two dietary supplement for 60 consecutive days. The supplements are administered orally and aims to improve cognitive performance in university students. Participants will also complete cognitive assessments before starting supplementation, 30 days after, and at the end of the intervention
PlaceboOther
Participants in this arm will receive a daily dose of an inert placebo that matches the supplement in appearance, taken orally for 60 consecutive days. The placebo is used as a control to compare the effects of the dietary supplement on cognitive performance. Participants will undergo the same cognitive assessments as the experimental groups.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement Participants in this arm will receive a daily dose of a dietary supplement for 60 consecutive days. The supplements are administered orally and aims to improve cognitive performance in university students. Participants will also complete cognitive assessments before starting supplementation, 30 days after, and at the end of the intervention. Receives: Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Participants in this arm will receive a daily dose of an inert placebo that matches the supplement in appearance, taken orally for 60 consecutive days. The placebo is used as a control to compare the effects of the dietary supplement on cognitive performance. Participants will undergo the same cognitive assessments as the experimental groups. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Change in cognitive performance measured Self-efficacy scale in higher education before starting supplementation, 30 days after, and at the end of the intervention. For reference, scores in the different dimensions (academic, higher education regulation, and social interaction) equal to or less than 3 indicate low levels of self-efficacy in the respective dimension. In turn, scores equal to or greater than 5 correspond to robust self-efficacy beliefs.
Measured: Baseline, 30 days and 60 days
Mood assessment
Change in mood is measured by DASS before starting supplementation, 30 days after, and at the end of the intervention. In the DASS, the scores are presented as a total score (between 0 and 63) and a score for the three subscales (between 0 and 21). The scores for each subscale are categorized into five degrees of severity: normal, mild, moderate, severe, and extremely severe. The higher the score, the greater the degree of severity.
Measured: Baseline, 30 days and 60 days]
Psychological Pathology Assessment
Psychological pathology assessment is measured by BSI before starting supplementation, 30 days after, and at the end of the intervention. BSI is assessed by calculating the Overall Severity Index (OSI), adding up all items on the BSI-18. OSI values ≥ 63 indicate psychological pathology.
Measured: Baseline, 30 days and 60 days]
Secondary outcomes (4)
Nutrition assessment
The shorter version of the Nutrition Council Appetite Assessment Questionnaire-the Simplified Appetite Nutrition Questionnaire (SANQ)-is being used in this study as a tool for measuring appetite in the group of participants. The SANQ consists of four items, grouped into a single domain. When added together, they generate the total questionnaire score, which can range from 4 to 20. The lower the score, the greater the risk of weight loss. In the original instrument, scores lower than or equal to 14 indicate a risk of weight loss of at least 5% in six months. Participants will be assessed before taking the dietary supplement and 60 days after.
Measured: Baseline and 60 days
Appetite assessment
Before the intervention and 60 days afterward, participants will be asked to rate their appetite using a visual appetite scale (VAS) to check for any changes and complete a simplified nutritional assessment questionnaire. This scale consists of a 100 mm long line without graduations, and participants should be instructed to mark a cross or a vertical line at the point on the scale where they consider their appetite to be. The point marked by the individual should be measured with the aid of a ruler, from the left end (minimum score zero mm) to the right (maximum score 100 mm), in order to quantify the resulting measurements. The results should be evaluated using the two measurement points. If the values remain the same, taking the supplements had no significant impact on the subjective perception of appetite.
Measured: Baseline and 60 days
Adherence to supplementation
Adherence will be monitored through a daily intake diary completed by participants, in which each participant will record their daily consumption of the supplement or placebo during the 60-day period. The record includes the day, month, and year. Participants will also complete a questionnaire on the occurrence of side effects at the end of the intervention (60 days).
Measured: 60 days
Evaluation of tolerance
Participants will also complete a questionnaire on the occurrence of side effects (absent, mild, moderate and severe) at the end of the intervention (60 days).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Jan 2025
- Primary completion30 Jun 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e Universitário
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Filipe Ferreira Linhares, Cooperativa de Ensino Superior, Politécnico e Universitário
- Investigators
- Rui Linhares, MSc, Principal investigator, Escola Superior de Saúde do Vale do Ave
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438236
- Sponsor's protocol ID
- Cognitive_Students
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deciding whether to share Individual Participant Data (IPD) involves weighing several considerations... we have to further reflect to make an informed decision about sharing IPD, balancing the potential benefits to the scientific community with the responsibility to protect participant rights and data integrity
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desempenho Cognitivo e Humor Após Ingestão de Suplemento Alimentar Por Estudantes do Ensino Superior
- ClinicalTrials.gov ID
- NCT07438236
- Acronym / sponsor ID
- Cognitive_Students
- Conditions
- Cognitive Performance, Mood, Dietary Supplement, Safety
- Keywords
- Dietary Supplement, Mental Health, Cognitive Performance, Self-eficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e UniversitárioUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 27 Feb 2026 (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.
This study investigates the effect of dietary supplementation on cognitive Performance and mood in university students over a 60-day period using a double-blind randomized controlled design. This study includes 75 participants, aged 18 or older. Participants will be randomly assigned to group I (n=25; will receive the supplement one), group II (n=25; will receive the supplement two), and group III (n=25; control/placebo).
Assessments will be conducted before starting supplementation, 30 days after, and at the end of the intervention to determine the effect of the supplementation on cognitive performance and mood. The main outcomes include cognitive status and mood measured by Depression Anxiety Stress Scales - (DASS), Brief Symptom Inventory (BSI) and Self-efficacy scale in higher education. Adherence to supplementation and potential side effects will also be assessed.
Based on the data obtained at these three assessment points, it will be possible to qualitatively address the actual effect of supplements on students' cognitive performance.
In addition, the participants nutritional status will also be assessed using the Simplified Appetite Nutrition Questionnaire (SANQ) and their perception of it using the Visual Appetite Scale (VAS). Both measurements will take place before the start of supplementation and at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Dietary SupplementDietary Supplement Participants in this arm will receive a daily dose of a dietary supplement for 60 consecutive days. The supplements are administered orally and aims to improve cognitive performance in university students. Participants will also complete cognitive assessments before starting supplementation, 30 days after, and at the end of the intervention. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a daily dose of an inert placebo that matches the supplement in appearance, taken orally for 60 consecutive days. The placebo is used as a control to compare the effects of the dietary supplement on cognitive performance. Participants will undergo the same cognitive assessments as the experimental groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants aged ≥ 18 years;
- students enrolled in Higher Technical Professional Courses and Bachelor's Degree Programs at ESSVA-IPSNCESPU;
- informed consent signed by the participant.
Key exclusion criteria (1 listed)
- participants with any type of disease diagnosed in the last 3 months, or recent use of specific supplementation for the cognitive component, were excluded to minimize biases that could influence the results.
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 |
|---|---|---|
| Dietary SupplementDietary Supplements Participants in this arm will receive a daily dose of two dietary supplement for 60 consecutive days. The supplements are administered orally and aims to improve cognitive performance in university students. Participants will also complete cognitive assessments before starting supplementation, 30 days after, and at the end of the intervention | Dietary supplement | Dietary Supplement |
| PlaceboParticipants in this arm will receive a daily dose of an inert placebo that matches the supplement in appearance, taken orally for 60 consecutive days. The placebo is used as a control to compare the effects of the dietary supplement on cognitive performance. Participants will undergo the same cognitive assessments as the experimental groups. | Other | Placebo |
Primary outcome
Cognitive performance
Time frame: Baseline, 30 days and 60 days
Change in cognitive performance measured Self-efficacy scale in higher education before starting supplementation, 30 days after, and at the end of the intervention. For reference, scores in the different dimensions (academic, higher education regulation, and social interaction) equal to or less than 3 indicate low levels of self-efficacy in the respective dimension. In turn, scores equal to or greater than 5 correspond to robust self-efficacy beliefs.
Mood assessment
Time frame: Baseline, 30 days and 60 days]
Change in mood is measured by DASS before starting supplementation, 30 days after, and at the end of the intervention. In the DASS, the scores are presented as a total score (between 0 and 63) and a score for the three subscales (between 0 and 21). The scores for each subscale are categorized into five degrees of severity: normal, mild, moderate, severe, and extremely severe. The higher the score, the greater the degree of severity.
Psychological Pathology Assessment
Time frame: Baseline, 30 days and 60 days]
Psychological pathology assessment is measured by BSI before starting supplementation, 30 days after, and at the end of the intervention. BSI is assessed by calculating the Overall Severity Index (OSI), adding up all items on the BSI-18. OSI values ≥ 63 indicate psychological pathology.
4 secondary outcomes
Nutrition assessment
Time frame: Baseline and 60 days
Appetite assessment
Time frame: Baseline and 60 days
Adherence to supplementation
Time frame: 60 days
Evaluation of tolerance
Time frame: 60 days
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. Deciding whether to share Individual Participant Data (IPD) involves weighing several considerations... we have to further reflect to make an informed decision about sharing IPD, balancing the potential benefits to the scientific community with the responsibility to protect participant rights and data integrity
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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.
Rui Linhares, MSc principal investigator
Escola Superior de Saúde do Vale do Ave
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Cognitive Performance and Mood, run by Cooperativa de Ensino Superior, Politécnico e Universitário at 1 site in Portugal.
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 3 inclusion and 1 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 27 Feb 2026. 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 Portugal. 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: Baseline, 30 days and 60 days). The study lists 3 primary outcomes in all. 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 27 Feb 2026.