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Completed

NCT Number: NCT07126717

Acute Effects of Zynamite® S in Cognitive Function and Mood

The present study sought to confirm the cognitive and mood benefits of a standardized soluble mango leaf extract, named as Zynamite® S. A placebo or a single dose of the botanical extract (100 mg) was administered and its acute effects on mental function and mood were evaluated before product intake, at 30 min, 3 h, and 5 h post-ingestion.

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Key information

Conditions

Cognitive Performance Mood

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Atlántico Medio

Tafira Baja, Las Palmas, 35118, Spain

About this study

The present study is a double-blind, randomized, placebo-controlled crossover clinical trial that aimed to evaluate the effects of a standardized soluble mango leaf extract (Zynamite® S) on cognitive performance and mood. The study included 88 healthy university students aged 18-25 years. Participants received a single 100 mg dose of Zynamite® S or a placebo. Cognitive performance was evaluated by using the Trail Making Test (TMT) to assess executive functions, the Digit Symbol Substitution Test (DSST) for processing speed, and the Stroop Color and Word Test and the Stroop Interference Test to evaluate selective attention and cognitive flexibility. Additionally, mood was assessed using the Spanish short version of the Profile of Mood States (POMS). All the assessments were conducted before product intake, at 30 min, 3 h, and 5 h post-ingestion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being registered as an undergraduate or postgraduate university student
  • Being between 18 and 25 years old
  • Being healthy and free of any relevant medical condition or illness

Exclusion criteria

  • Suffering from chronic diseases such as asthma, type 1 diabetes, thyroid diseases (such as hypothyroidism or hyperthyroidism), autoimmune disorders (such as Crohn's disease), and psychiatric conditions such as anxiety disorders, major depression, eating disorders (anorexia, bulimia), attention deficit hyperactivity disorder (ADHD), among others
  • Being pregnant or lactating
  • Having any known intolerance, hypersensitivity, or allergies to any of the ingredients of the investigational products
  • Having intestinal malabsorption problems, as well as learning difficulties, dyslexia, eye problems, or color blindness
  • Intaking of psychoactive substances or medications that could influence the study results, such as consuming >500 mg of caffeine per day (>6 cups of 150 ml filtered coffee) and/or alcohol
  • Having comprehension or communication difficulties that prevent full understanding of the informed consent or effective participation in the study, such as autism spectrum disorders, aphasia, or intellectual disability

Treatment and study plan

Placebo

Dietary Supplement

Food-grade maltodextrin

Zynamite® S

Dietary Supplement

Water-soluble mango leaf extract standardized to 60% of mangiferin

Primary outcomes

  1. Changes in Trail Making Test (TMT) Score

    Time frame: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.

    Changes in the Trail Making Test (TMT) score will be used to evaluate executive functions between placeobo and Zynamite® S groups.

    This test is divided into two parts wtih 25 items each: Part A (TMT-A), which evaluates psychomotor attention and speed and involves connecting consecutively numbered circles, and Part B (TMT-B), which requires connecting alternating circles of letters and numbers and is used to measure executive function. A longer time taken to complete the test is interpreted as poorer performance.

  2. Changes in Digit symbol substitution test (DSST) Score

    Time frame: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.

    Changes in the Digit symbol substitution test (DSST) will be employed to compare performance on processing speed, attention, and working memory between placebo and Zynamite® S groups.

    DSST is a paper-and-pencil cognitive test presented on a single sheet of paper, requiring the subject to match symbols with numbers according to a key located at the top of the page. The subject copies the symbol into spaces beneath a row of numbers. The score is based on the number of correct symbols the participant manages to substitute within 90 s.

  3. Changes in Stroop Color and Word & Stroop Interference Score

    Time frame: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.

    Changes in the Stroop Color and Word Test and Stroop Interefernce Test will be used to assess cognitive functions, such as selective attention and cognitive flexibility between placebo and Zynamite® S groups.

    The Stroop Color and Word Test consists on three 45-second tasks. First, the participants read color words printed in black ink (the 'P' score). Next, they name the ink color of "XXXX" symbols (the 'C' score). In the final interference stage, the participant must state the ink color of a word that is printed in a conflicting color, such as the word "BLUE" printed in red ink (the 'PC' score). These three scores are then used to calculate a final T score of interference, where a higher score indicates better performance and attention control.

Secondary outcomes

  1. Changes in Profile of Mood States (POMS) Score

    Time frame: At baseline (30 minutes before supplement intake), at 30 minutes, 3 hours, and 5 hours after supplement intake.

    Changes on the Profile of Mood States (POMS) score will be used to evaluate mood and well-being between placebo and Zynamite® S groups.

    Participants will complete the Spanish short version of the POMS 65-item questionnaire, which includes a total of 6 subscales: tension (score range 0 to 36), depression (score range 0 to 60), anger (score range 0 to 48), fatigue (score range 0 to 28), vigor (score range 0 to 32), and confusion (score range 0 to 28), as well as a total mood disturbance score (score range -32 to 200). The total mood disturbance score is calculated by summing the five negative subscale scores (tension, depression, anger, fatigue, and confusion) and subtracting the vigor score. Higher scores for the total mood disturbance indicate a greater degree of mood disturbance.

Sponsors and collaborators

Lead sponsor

Nektium Pharma SL

Industry

Collaborators

  • University of Atlántico Medio

Registry information

Official study title

Confirmatory Study on the Acute Effects of Zynamite® S on Cognitive Function and Mood in University Students: a Randomized, Double-blind, Placebo-controlled Crossover Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

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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