Zynamite® in Cognition and Mood in University Students

NCT06651710 | Completed

• 1 other identifier: University
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of a single dose of ZynS on cognitive function (memory, concentration, attention, and mental agility) in college students and will test the efficacy of this treatment on mood (anger, fatigue, vigor, agreeableness, tension, and depression).

Conditions

University Student

Outcome Measures

Primary Outcomes (5)

• del POMS (Profile Of Mood States)

  It has a total of 6 subscales: tension (score range, 0-36), depression (score range, 0-60), anger (score range, 0-48), fatigue (score range, 0-28), vigor (score range, 0-32), and confusion (score range, 0-28), and a total mood disturbance (score range, -32 to 200). Each of the questions will be scored from 0 (not at all) to 4 (very much so). 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 score indicate a greater degree of mood disturbance.

  Up to fourteen days

• Rey Auditory Verbal Learning Test (RAVLT)

  The Rey Auditory Verbal Learning Test (RAVLT) is a neuropsychological test used to assess short- and long-term memory. The structure of the RAVLT consists of several parts: * Learning: Participants are read a list of 15 unrelated words (List A) in five consecutive trials. * Delayed Recall: The participant is asked to recall and repeat back the words from List A. To establish the score for this test, the following elements are considered to calculate the scores: * Total learning score: The total number of words correctly recalled in the five trials of List A is added up. Normal scores are 6 words correctly recalled in the first trial and 12 or 13 in the fifth trial. This reflects the ability for learning and short-term memory. * Delayed Recall: The number of words recalled from List A after the time interval without practice (20-30 minutes) is noted. This assesses long-term memory. The score can range from 0 to 15 points.

  Up to fourteen days

• Trail Making Test (TMT)

  It is used to assess executive function and specifically measures timed motor and visual tasks. This test is divided into two parts: Part A (TMT-A), which assesses psychomotor attention and speed and consists of connecting consecutively numbered circles; and Part B (TMT-B), which is based on connecting alternating circles of letters and numbers and measures executive function. A longer time spent completing the test is interpreted as worse performance.

  Up to fourteen days

• The Digit Symbol Substitution Test (DSST)

  Is a paper-and-pencil cognitive test presented on a single sheet of paper that requires the subject to match symbols to numbers according to a key located at the top of the page. The subject copies the symbol into spaces below a row of numbers. Scoring is based on the number of correct symbols the participant manages to substitute in 90 seconds of time.

  Up to fourteen days

• Stroop Color and Word Test

  It is used to assess selective attention. This test has a total of 3 slides, each lasting 45 seconds, with a total time of 5 minutes to complete the entire test. In order to read each slide correctly, it must be read from top to bottom and from left to right. The first slide (Stroop Word) is made up of 100 words in which the words "RED", "BLUE" and "GREEN" are repeated, ordered randomly and printed in black ink. This part assesses the number of words read in 45 seconds. After this time, participants must circle the last word they have read. The second slide (Stroop Color) is made up of 100 identical elements "XXXX" in blue, red and green ink. The participant must name the colour of "XXXX" as quickly as possible. Finally, the third slide (Stroop Word-Color) consists of 100 written words that refer to a colour, but are printed in a different colour. Participants must say the color of the ink each word is written in. Higher scores indicate better performance.

  Up to fourteen days

Study Arms (3)

Placebo

NO INTERVENTION

Zynamite® soluble 100mg

EXPERIMENTAL

Other: Zynamite

Zynamite® soluble 150mg

EXPERIMENTAL

Other: Zynamite

Interventions

Zynamite OTHER

Two doses of Mangifera indica leaf extract in its soluble form, Zynamite® S, 100 mg of which 60 mg is mangiferin and 150 mg of which 90 mg is mangiferin, will be tested against a placebo. On the day of the test, the supplements will be administered 30 minutes before the start of the test. The supplements or placebo will be administered in cellulose capsules or similar and accompanied by a glass of water.

Zynamite® soluble 100mg; Zynamite® soluble 150mg

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be an active undergraduate or graduate student
• Be between 18 and 25 years of age
• Be healthy and free of any relevant medical condition or disease.

You may not qualify if:

• Suffer 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; ii) Pregnancy or breastfeeding.
• Known intolerance, hypersensitivity or allergies to any of the ingredients of the products under investigation;
• Intestinal absorption problems, as well as learning difficulties, dyslexia, eye problems or color blindness;
• Intake of psychoactive substances or medications that may influence the results of the study, 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

University of Atlántico Medio

Las Palmas de Gran Canaria, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: May 13, 2024
• Primary Completion: June 3, 2024
• Study Completion: June 10, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

ES (1)