Acute Effects of Zynamite® S in Cognitive Function and Mood

NCT07126717 | Completed

• 1 other identifier: ZYNS_HCT_2025.01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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, and 5 h post-ingestion.

Conditions

Cognitive Performance; Mood

Keywords

Zynamite® S; Mango Leaf Extract; Cognitive Performance; Mood

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Changes in Profile of Mood States (POMS) Score

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsule containing food-grade maltodextrin

Dietary Supplement: Placebo

Zynamite® S 100mg

EXPERIMENTAL

Capsule containing 100 mg of soluble mango leaf extract (Zynamite® S) standardized to 60% of mangiferin

Dietary Supplement: Zynamite® S

Interventions

Placebo DIETARY_SUPPLEMENT

Food-grade maltodextrin

Placebo

Zynamite® S DIETARY_SUPPLEMENT

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

Zynamite® S 100mg

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektium Pharma SL: lead
• University of Atlántico Medio: collaborator

Study Sites (1)

University of Atlántico Medio

Tafira Baja, Las Palmas, 35118, Spain

Location

Related Publications (12)

• 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.

  PMID: 40284006 BACKGROUND

• 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.

  PMID: 39942566 BACKGROUND

• 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.

  PMID: 33802176 BACKGROUND

• 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.

  PMID: 36014874 BACKGROUND

• 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.

  PMID: 25064341 BACKGROUND

• 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.

  PMID: 28410265 BACKGROUND

• 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.

  PMID: 33424383 BACKGROUND

• 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.

  PMID: 33641782 BACKGROUND

• 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.

  PMID: 36117559 BACKGROUND

• 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.

  PMID: 30013719 BACKGROUND

• 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.

  PMID: 32473365 BACKGROUND

• 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.

  PMID: 32717999 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: May 12, 2025
• Primary Completion: June 2, 2025
• Study Completion: June 9, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)