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Cognitive PerformanceNCT07126717

Acute Effects of Zynamite® S in Cognitive Function and Mood

A study testing Zynamite® S in people with Cognitive Performance and Mood, run by Nektium Pharma SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Performance, Mood
What is being tested?
Zynamite® S
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteSpain
Study dates
12 May 2025to 9 Jun 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 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Atlántico Medio

    Tafira Baja, Las Palmas, 35118

Other trials in Spain

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Placebo, Zynamite® S
Keywords
Zynamite® S, Mango Leaf Extract, Cognitive Performance, Mood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Food-grade maltodextrin

  • Zynamite® SDietary supplement

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

Study groups in NCT07126717
Study groupRoleWhat they receive
PlaceboPlacebo comparatorCapsule containing food-grade maltodextrin
Receives: Dietary Supplement: Placebo
Zynamite® S 100mgExperimentalCapsule containing 100 mg of soluble mango leaf extract (Zynamite® S) standardized to 60% of mangiferin
Receives: Dietary Supplement: Zynamite® S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Trail Making Test (TMT) Score

    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.

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

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

    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.

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

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

    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.

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

Secondary outcomes (1)

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start12 May 2025
  3. Primary completion2 Jun 2025
  4. Study completion9 Jun 2025

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07126717
Sponsor's protocol ID
ZYNS_HCT_2025.01
Status last verified
Aug 2025
First submitted
11 Aug 2025
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Castellote-Caballero Y, Beltran-Arranz A, Aibar-Almazan A, Carcelen-Fraile MDC, Rivas-Campo Y, Lopez-Rios L, Vega-Morales T, Gonzalez-Martin AM. Acute Supplementation of Soluble Mango Leaf Extract (Zynamite(R) S) Improves Mental Performance and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Pharmaceuticals (Basel). 2025 Apr 14;18(4):571. doi: 10.3390/ph18040571.

    PubMed 40284006

  • Fuentes-Rios D, Sanchez-Rodriguez A, Lopez-Rios L, Garcia-Gonzalez E, Martinez-Canton M, Galvan-Alvarez V, Gallego-Selles A, Martin-Rincon M, Calbet JAL, Vega-Morales T. Human Pharmacokinetic Profiling and Comparative Analysis of Mangiferin and Its Monosodium Derivative from Mangifera indica Extracts Using UHPLC-MS/MS with 1H NMR and MALDI-TOF Confirmation. Molecules. 2025 Jan 21;30(3):461. doi: 10.3390/molecules30030461.

    PubMed 39942566

  • Sharif S, Guirguis A, Fergus S, Schifano F. The Use and Impact of Cognitive Enhancers among University Students: A Systematic Review. Brain Sci. 2021 Mar 10;11(3):355. doi: 10.3390/brainsci11030355.

    PubMed 33802176

  • Malik M, Tlustos P. Nootropics as Cognitive Enhancers: Types, Dosage and Side Effects of Smart Drugs. Nutrients. 2022 Aug 17;14(16):3367. doi: 10.3390/nu14163367.

    PubMed 36014874

  • Jangra A, Lukhi MM, Sulakhiya K, Baruah CC, Lahkar M. Protective effect of mangiferin against lipopolysaccharide-induced depressive and anxiety-like behaviour in mice. Eur J Pharmacol. 2014 Oct 5;740:337-45. doi: 10.1016/j.ejphar.2014.07.031. Epub 2014 Jul 23.

    PubMed 25064341

  • Cao C, Su M, Zhou F. Mangiferin inhibits hippocampal NLRP3 inflammasome and exerts antidepressant effects in a chronic mild stress mice model. Behav Pharmacol. 2017 Aug;28(5):356-364. doi: 10.1097/FBP.0000000000000305.

    PubMed 28410265

  • Lum PT, Sekar M, Gan SH, Pandy V, Bonam SR. Protective effect of mangiferin on memory impairment: A systematic review. Saudi J Biol Sci. 2021 Jan;28(1):917-927. doi: 10.1016/j.sjbs.2020.11.037. Epub 2020 Nov 13.

    PubMed 33424383

  • Lei LY, Wang RC, Pan YL, Yue ZG, Zhou R, Xie P, Tang ZS. Mangiferin inhibited neuroinflammation through regulating microglial polarization and suppressing NF-kappaB, NLRP3 pathway. Chin J Nat Med. 2021 Feb;19(2):112-119. doi: 10.1016/S1875-5364(21)60012-2.

    PubMed 33641782

  • Li HW, Lan TJ, Yun CX, Yang KD, Du ZC, Luo XF, Hao EW, Deng JG. Mangiferin exerts neuroprotective activity against lead-induced toxicity and oxidative stress via Nrf2 pathway. Chin Herb Med. 2019 Dec 14;12(1):36-46. doi: 10.1016/j.chmed.2019.12.002. eCollection 2020 Jan.

    PubMed 36117559

  • Alberdi E, Sanchez-Gomez MV, Ruiz A, Cavaliere F, Ortiz-Sanz C, Quintela-Lopez T, Capetillo-Zarate E, Sole-Domenech S, Matute C. Mangiferin and Morin Attenuate Oxidative Stress, Mitochondrial Dysfunction, and Neurocytotoxicity, Induced by Amyloid Beta Oligomers. Oxid Med Cell Longev. 2018 Jun 14;2018:2856063. doi: 10.1155/2018/2856063. eCollection 2018.

    PubMed 30013719

  • Lopez-Rios L, Wiebe JC, Vega-Morales T, Gericke N. Central nervous system activities of extract Mangifera indica L. J Ethnopharmacol. 2020 Oct 5;260:112996. doi: 10.1016/j.jep.2020.112996. Epub 2020 May 27.

    PubMed 32473365

  • Wightman EL, Jackson PA, Forster J, Khan J, Wiebe JC, Gericke N, Kennedy DO. Acute Effects of a Polyphenol-Rich Leaf Extract of Mangifera indica L. (Zynamite) on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study. Nutrients. 2020 Jul 23;12(8):2194. doi: 10.3390/nu12082194.

    PubMed 32717999

Questions about this trial

What is this clinical trial studying?

A study testing Zynamite® S in people with Cognitive Performance and Mood, run by Nektium Pharma SL at 1 site in Spain.

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 6 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 17 Aug 2025. 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 Spain. 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?

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.). 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?

On the ClinicalTrials.gov record for NCT07126717, which also lists 12 linked publications.

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 17 Aug 2025.

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