Cognitive Performance and Mood After Ingestion of Dietary Supplement by University Students

NCT07438236 | Completed

• 1 other identifier: Cognitive_Students
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Performance; Mood; Dietary Supplement; Safety

Keywords

Dietary Supplement; Mental Health; Cognitive Performance; Self-eficacy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 30 days and 60 days]

Secondary Outcomes (4)

• Nutrition assessment

  Baseline and 60 days

• Appetite assessment

  Baseline and 60 days

• Adherence to supplementation

  60 days

• Evaluation of tolerance

  60 days

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Dietary Supplement DIETARY_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

Dietary Supplement

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cooperativa de Ensino Superior, Politécnico e Universitário: lead

Study Sites (1)

Escola Superior de Saúde do Vale do Ave

Vila Nova de Famalicão, Braga District, 4760-409, Portugal

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rui Linhares, MSc

  Escola Superior de Saúde do Vale do Ave

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 27, 2026
• Study Start: January 2, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

PT (1)