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

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.

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 Overview

• Status: Completed
• Conditions: Mood; Cognitive Performance; Safety; Dietary Supplement
• Intervention / Treatment: Dietary supplement: Dietary Supplement; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga District
    • Vila Nova de Famalicão, Braga District, Portugal, 4760-409
      • Escola Superior de Saúde do Vale do Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Supplement; 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; 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
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	60 days

Collaborators and Investigators

• Sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
• Investigators: Principal Investigator: Rui Linhares, MSc, Escola Superior de Saúde do Vale do Ave

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Dietary Supplement; Cognitive Performance; Self-eficacy
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: Cognitive_Students

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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

Drug and device information, study documents

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