Clinical trial NCT05182450: Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
Official title: Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention
Cognition
Mood
Keywords: mood
cognitive function
mango leaf
mango
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

1. Participants aged 18 to 45 years, inclusive
2. Self-reported good health
3. Willingness to abstain from consumption of caffeine within 12 h of testing
4. Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
5. 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
6. 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

Exclusion Criteria:

1. Failure to meet any one of the inclusion criteria
2. Have any pre-existing medical condition/illness which will impact taking part in the study, interact with the active treatments or impede performance
3. 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
4. Have sleep disorders or are taking sleep aid medication
5. Major trauma or major surgical event within 6 months of screening
6. Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
7. Exposure to mango leaf extract (MLE) within 30 d prior to screening
8. History of cancer in the prior two years, except for non-melanoma skin cancer
9. Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
10. 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.
11. Self-report excessive leisure time physical activity (\> 7 strenuous bouts per week)
12. Have a current or chronic gastrointestinal, sleep, or psychiatric disorders including medically diagnosed anxiety and depression
13. Work night shifts or follow a variable work pattern that results in irregular sleep pattern
14. Are pregnant, trying to get pregnant or lactating
15. Smoke tobacco, vape nicotine or use nicotine replacement products (including occasional social smoking)
16. Illegal/recreational drug use
17. Fail to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
18. Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
19. Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
20. Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
21. Have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism, ADHD).
22. Excessive caffeine intake (\>500 mg per day)
23. Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements taken are out of choice and not medically prescribed or advised)
24. Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
25. Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
26. Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
27. Suffers from frequent migraines that require medication (more than or equal to 1 per month)
28. Any known active infections
29. Are non-compliant with regards treatment consumption
30. Does not have a bank account (required for payment)

Primary outcomes:
measure: Accuracy of attention
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Secondary outcomes:
measure: General mood and psychological state, including depression and anxiety: VAMS
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: General mood and psychological state, including depression and anxiety: POMS
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: General mood and psychological state, including depression and anxiety: S-VAS
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive domain factor scores
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Global cognitive performance measures: Speed
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Global cognitive performance measures: Accuracy
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive performance: Episodic long term memory
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive performance: Attention
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive performance: Working memory
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive performance: Executive function
timeFrame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
measure: Cognitive function and mental fatigue during extended performance of cognitively demanding tasks
timeFrame: 30, 180 and 300 minutes post-dose compared to placebo
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University, Brain Performance and Nutrition Research Centre
Study officials:
affiliation: U. Northumbria, Brain Performance and Nutrition Research Centre, Department of Psychology
name: Fiona Dodd, PhD
role: PRINCIPAL_INVESTIGATOR
References: