AttentionNCT05182450
Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
A study testing Mango leaf extract capsule in people with Attention and Cognition, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Mango leaf extract capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2022to 20 Jun 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Failure to meet any one of the inclusion criteria
- 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.)
Show all 30Show fewer
- 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
- Fail to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
- Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- Have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism, ADHD).
- Excessive caffeine intake (>500 mg per day)
- 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)
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Any known active infections
- Are non-compliant with regards treatment consumption
- Does not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University, Brain Performance and Nutrition Research Centre
Newcastle upon Tyne, NE1 8ST
About this study
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).
- Being tested
- Mango leaf extract capsule, Placebo capsule
- Keywords
- mood, cognitive function, mango leaf, mango
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango leaf extract capsuleOther
Single dose
Placebo capsuleOther
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Active capsule | Experimental | Colored capsule containing 300 mg mango leaf extract (Zynamite®) standardized to contain ≥ 60% mangiferin. Supplied by PLT Health Solutions, Inc. Receives: Other: Mango leaf extract capsule |
| Placebo capsule | Placebo comparator | Colored capsule, appearance-matched to the active experimental capsule Receives: Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Visual Analogue Mood Scales (VAMS). Current subjective position marked on 100 mm lines anchored at either end by 18 antonyms (e.g. 'alert-inattentive', 'lethargic-energetic'). Better mood scores are a better outcome.
Measured: 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
Profile of Mood States (POMS) consisting of 65 adjectives rated on a 0-4 scale. Better mood scores are a better outcome.
Measured: 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
Stress Visual Analogue Mood Scales (S-VAS). Four items (anxious, stressed, relaxed, calm) rated not at all to extremely on 100 mm lines. Better mood scores are a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive domain factor scores
Composite cognitive factors (speed of attention, working memory, speed of memory and episodic memory) averaged across individual tasks. Higher scores are better.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Global cognitive performance measures: Speed
Speed of cognitive performance comprising reaction time (msec) data averaged from all of the computerized cognitive assessment tasks that return speed data. Faster average speed is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Global cognitive performance measures: Accuracy
Accuracy of cognitive performance comprising % accuracy data averaged from all of the computerized cognitive assessment tasks that return accuracy data. Higher average % accuracy is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Episodic long term memory
A computerized series of individual cognitive tasks are presented on screen. Test components are word recall, word recognition and picture recognition. Better task performance is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Attention
A computerized series of individual cognitive tasks are presented on screen. Test components are choice reaction time, digit vigilance and simple reaction time. Better task performance is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Working memory
A computerized series of individual cognitive tasks are presented on screen. Test components are numeric working memory and corsi blocks. Better task performance is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Executive function
A computerized peg and ball cognitive task is presented on screen. Better task performance is a better outcome.
Measured: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive function and mental fatigue during extended performance of cognitively demanding tasks
Cognitive Demand Battery (CDB) of component tasks: Serial 3s/7s, Rapid Visual Information Processing task (RVIP), Mental Fatigue Visual Analog Scale (VAS). 30 minute test (10 minute computerized assessment run three times in succession). Higher function and lower fatigue are better outcomes.
Measured: 30, 180 and 300 minutes post-dose compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start4 Jan 2022
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fiona Dodd, PhD, Principal investigator, U. Northumbria, Brain Performance and Nutrition Research Centre, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182450
- Sponsor's protocol ID
- PEP-2102
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38665302
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Mango Leaf Extract on Cognitive Function in Healthy Adults: A Double-Blind, Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT05182450
- Acronym / sponsor ID
- PEP-2102
- Keywords
- mood, cognitive function, mango leaf, mango
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active capsule | Experimental | Other: Mango leaf extract capsuleColored capsule containing 300 mg mango leaf extract (Zynamite®) standardized to contain ≥ 60% mangiferin. Supplied by PLT Health Solutions, Inc. |
| Placebo capsule | Placebo comparator | Other: Placebo capsuleColored capsule, appearance-matched to the active experimental capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (30 listed)
- Failure to meet any one of the inclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango leaf extract capsuleSingle dose | Other | Active capsule |
| Placebo capsuleSingle dose | Other | Placebo capsule |
Primary outcome
Accuracy of attention
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Average % correct of attention tasks - choice reaction time, digit vigilance and 3 x rapid visual information processing task). Higher accuracy is better.
11 secondary outcomes
General mood and psychological state, including depression and anxiety: VAMS
Time frame: 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
Time frame: 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
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive domain factor scores
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Global cognitive performance measures: Speed
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Global cognitive performance measures: Accuracy
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Episodic long term memory
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Attention
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Working memory
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive performance: Executive function
Time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo
Cognitive function and mental fatigue during extended performance of cognitively demanding tasks
Time frame: 30, 180 and 300 minutes post-dose compared to placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 38665302Dodd 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Dodd, PhD principal investigator
U. Northumbria, Brain Performance and Nutrition Research Centre, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango leaf extract capsule in people with Attention and Cognition, run by PepsiCo Global R&D at 1 site in United Kingdom.
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 6 inclusion and 30 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 14 Nov 2022. 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 United Kingdom. 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?
Accuracy of attention (time frame: Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo). 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 NCT05182450, which also lists 1 linked publication.
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 14 Nov 2022.