Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study

NCT05182450 | Completed

• 1 other identifier: PEP-2102
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of a single dose (300 mg) of Mango Leaf Extract compared to a placebo on cognitive function, including during cognitively demanding task performance. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB), and Profile of Mood States (POMS), visual analogue mood scales (VAMS), and Stress Visual Analogue Scales (S-VAS) with assessments taking place at baseline, 30 minutes, 180 minutes and 300 minutes post treatment, on two separate testing days separated by 7 days (minimum).

Conditions

Attention; Cognition; Mood

Keywords

mood; cognitive function; mango leaf; mango

Outcome Measures

Primary Outcomes (1)

• Accuracy of attention

  Average % correct of attention tasks - choice reaction time, digit vigilance and 3 x rapid visual information processing task). Higher accuracy is better.

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

Secondary Outcomes (11)

• General mood and psychological state, including depression and anxiety: VAMS

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

• General mood and psychological state, including depression and anxiety: POMS

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

• General mood and psychological state, including depression and anxiety: S-VAS

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

• Cognitive domain factor scores

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

• Global cognitive performance measures: Speed

  Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo

Study Arms (2)

Active capsule

EXPERIMENTAL

Colored capsule containing 300 mg mango leaf extract (Zynamite®) standardized to contain ≥ 60% mangiferin. Supplied by PLT Health Solutions, Inc.

Other: Mango leaf extract capsule

Placebo capsule

PLACEBO COMPARATOR

Colored capsule, appearance-matched to the active experimental capsule

Other: Placebo capsule

Interventions

Mango leaf extract capsule OTHER

Single dose

Active capsule

Placebo capsule OTHER

Single dose

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18 to 45 years, inclusive
• Self-reported good health
• Willingness to abstain from consumption of caffeine within 12 h of testing
• Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
• Willing to refrain from 'over the counter' medications (e.g., pain medication) and stimulant medication for 12 hours, seasonal allergy/hayfever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
• Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator

You may not qualify if:

• Have any pre-existing medical condition/illness which will impact taking part in the study, interact with the active treatments or impede performance
• Current use of prescription medication (no antibiotics within the last 4 weeks) NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, where participants may be able to progress to screening
• Have sleep disorders or are taking sleep aid medication
• Major trauma or major surgical event within 6 months of screening
• Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
• Exposure to mango leaf extract (MLE) within 30 d prior to screening
• History of cancer in the prior two years, except for non-melanoma skin cancer
• Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
• Food allergies/intolerances/sensitivities to any ingredients in the study products and study meals (including related foods/beverages/products) and or unwillingness to eat or dislike for the study meals.
• Self-report excessive leisure time physical activity (\> 7 strenuous bouts per week)
• Have a current or chronic gastrointestinal, sleep, or psychiatric disorders including medically diagnosed anxiety and depression
• Work night shifts or follow a variable work pattern that results in irregular sleep pattern
• Are pregnant, trying to get pregnant or lactating
• Smoke tobacco, vape nicotine or use nicotine replacement products (including occasional social smoking)
• Illegal/recreational drug use

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Northumbria University, Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (1)

• Dodd FL, Kennedy DO, Johnson J, Haworth E, Greener JP, Jackson PA. Acute effects of mango leaf extract on cognitive function in healthy adults: a randomised, double-blind, placebo-controlled crossover study. Front Nutr. 2024 Apr 11;11:1298807. doi: 10.3389/fnut.2024.1298807. eCollection 2024.

  PMID: 38665302 DERIVED

Study Officials

• Fiona Dodd, PhD

  U. Northumbria, Brain Performance and Nutrition Research Centre, Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Capsules will disguise potential differences in colour/particle size of powders
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 10, 2022
• Study Start: January 4, 2022
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)