Cognitive ChangeMLE-ZYNNCT04299217
Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Stress
A study testing Zynamite® in people with Cognitive Change and Stress, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This study aims to assess the effects of a single dose of Zynamite® on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Stress
- What is being tested?
- Zynamite®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2019to 17 Mar 2020
- 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 must self-assess themselves as being in good health
- Aged 18 to 45 years at the time of giving consent
Who cannot join
- Participants are not eligible to take part if they:
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled hay fever. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications 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. As above, 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, participants may be able to progress to screening.
- 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
- Are pregnant, seeking to become pregnant or lactating.
Show all 31Show fewer
- Have learning and/or behavioural difficulties such as dyslexia or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoke tobacco or vape nicotine or use nicotine replacement products
- excessive caffeine intake (>500 mg per day)
- Have relevant food intolerances/ sensitivities
- Have taken antibiotics within the past 4 weeks
- Have taken dietary supplements eg. 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 they are 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)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- 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)
- Sleep disorders or are taking sleep aid medication
- Have oral disease
- Any known active infections
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption (see 4.3)
- Participants will be excluded from the blood sampling element of the study if:
- Have any known active infections
- They currently have, previously have had or think they are at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus (HIV)
- They have ever had breast cancer and/or a mastectomy
- They have haemophilia or any similar clotting/blood disorder
- They have they had unprotected sexual intercourse with any person from an HIV high risk population
- They have ever been involved in intravenous drug use
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Physiological and Psychological Responses to Stress in Healthy Adults
This study aims to assess the effects of a single dose of Zynamite® on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress.
Seventy-two healthy healthy males (50%) and females (50%) aged 18-45 years will be recruited from the general population. Participants will be randomised to receive either Zynamite® or placebo at testing visit 1, then the treatment they have not already received at testing visit 2. A single acute dose will be administered on each of the two testing visits, with at least a seven day washout period in between. The study is quantitative; participants will complete questionnaires assessing mood, cognitive tasks and an Observed Multitasking Stressor (OMS) task (with saliva samples, and blood samples for 50% of the sample). The cognitive/mood assessments will take place at baseline, then at 30, 180 and 300 minutes post-dose. The OMS assessments will take place at baseline then between 90 and 130 minutes post-dose. For participants in the bloods sub-sample, blood samples will be taken at baseline and after the 300 minute post-dose assessment. Both testing visits will be identical apart from the treatment allocated.
Read the detailed description
The proposed study will assess the effects of a single dose of Zynamite® on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress. Zynamite®'s effects will also be assessed in terms of mood, and its ability to modulate the physiological and psychological response to an acute stressor.
The study will follow a randomised, double-blind, placebo-controlled, balanced cross-over design, with treatment (Zynamite®, placebo) as a factor. Seventy-two healthy males (50%) and females (50%) aged 18-45 years will be recruited using opportunity sampling. Participants will be randomised to receive either Zynamite® or placebo at testing visit 1, then the treatment they have not already received at testing visit 2. A single acute dose will be administered on each of the two testing visits, with at least a seven day washout period in between.
Testing will take place in a suite of testing facilities at the Brain, Performance and Nutrition Research Centre with participants visually isolated from each other. Participants will attend the laboratory on 3 separate occasions, an introductory visit and two testing days (Day 1 and Day 2).
Visit 1 (screening/training) The Introductory visit to the laboratory will comprise: briefing on requirements of the study, obtaining of informed consent, health screening, completion of the Caffeine Consumption Questionnaire (CCQ), training on the cognitive and mood measures and collection of demographic data.
Visit 2 Participants will attend the laboratory at a pre-arranged time in the morning having consumed a standardised breakfast of cereal and/ or toast at home no later than an hour before arrival. They must have refrained from alcohol for 24 hours and caffeine overnight. On arrival on each day participants will have a baseline rested measurement taken of their heart rate (HR) and galvanic skin response (GSR) taken, will complete the Profile of Mood States (POMS)(Mood/depression/arousal) followed by a 60 minute computerised cognitive assessment (COMPASS - including the Cognitive Demand Battery). This will be followed by completion of the Observed Multitasking Stressor (OMS) test session. This 5-10 minute OMS takes place under observation (which will include being observed by a panel and video and voice recordings) comprises provision of a saliva sample, completion of the State Trait Anxiety Inventory (STAI)-state, and visual analogue scales (VAS) which are completed before and after the stressor. The stressor comprises the performance of a verbal Serial 7s subtraction task whilst concomitantly performing a computerised tracking task. Finally a further saliva sample is taken. HR and GSR are recorded throughout. After the first cognitive/OMS assessment participants will take their treatment for the day and will undergo cognitive/mood assessments identical to the above at 30 minutes, 180 minutes and 300 minutes post-dose. The post-dose OMS assessment will take place between 90 and 130 minutes post-dose.
Blood samples will be taken from 50% of the participants both before the pre-dose, baseline assessment and after the 300 minute post-dose assessment. The two testing days (Day 1/Day2) will be identical, with the exception that participants will take a different treatment on each day.
Visit 3 (at least 7 days later) The methodology during this visit will be identical to visit 2, with the exception that participants will consume a different treatment during this visit.
- Conditions
- Cognitive Change, Stress
- Being tested
- Zynamite®, Placebo
- Keywords
- cognition, cognitive performance, stress, nutrition, memory, attention, mental performance, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zynamite®Dietary supplement
Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain 60% of the polyphenol mangiferin. Zynamite® is classified as a food or food supplement and is available for purchase within the EU. Zynamite® is not associated with any significant deleterious side effects.
PlaceboOther
Placebo comparator (carrier)
| Study group | Role | What they receive |
|---|---|---|
| Mango Leaf Extract | Active comparator | 300 mg Mangifera indica (mango) leaf extract standardized to ≥ 60% mangiferin (Zynamite®), plus carrier Receives: Dietary Supplement: Zynamite® |
| Placebo | Placebo comparator | Carrier (placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood measures- Profile of Mood States (POMS)
Profile of Mood States (POMS)
Measured: Prior to (baseline) and following one dose of treatment (at 30, 180 and 300 minutes post dose)
Mood measures- Stress Visual Analogue Scales (VAS)
Stress Visual Analogue Scales (VAS) (out of 100; higher score is more anxious/stressed/relaxed/calm) (pre-dose baseline and 30, 180 and 300 min post dose
Measured: Following one dose of treatment at 30, 180 and 300 minutes post-dose
Mood measures- State Trait Anxiety Inventory (STAI)
State Trait Anxiety Inventory (STAI) (20-80; higher is more anxious) (pre-OMS at baseline and 90 - 130 min post-dose).
Measured: Following one dose of treatment at 90-130 minutes post-dose
Cognitive Function- Individual task
Individual task parameters including word recall, word recognition, picture recognition, stroop, peg and ball, numeric working memory, digit vigilance, choice reaction time, simple reaction time, corsi blocks (pre-dose baseline and 30, 180 and 300 min post-dose)
Measured: Following one dose of treatment at 30, 180 and 300 min post-dose
Cognitive Function- Composite cognitive factors
Composite cognitive factors of the aforementioned tasks e.g. Episodic memory, Working Memory, Attention, Spatial Working Memory, Executive Function, Episodic Memory (pre-dose baseline and 30, 180 and 300 min post-dose)
Measured: Following one dose of treatment at 30, 180 and 300 min post-dose
Cognitive Function- cognitively demanding tasks
Cognitive function and mental fatigue during extended performance of cognitively demanding tasks (Cognitive Demand Battery [comprising mental arithmetic and attention tasks] (pre-dose baseline and 30, 180 and 300 min post-dose)
Measured: Following one dose of treatment at 30, 180 and 300 min post-dose
Cognitive Function under stressful conditions
Cognitive performance (multi tasking using Serial 7s and tracking simultaneously) during acute stress as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).
Measured: Following one dose of treatment at 90-130 mins post-dose
Psychological stress response
Modulation of the psychological response to acute stress (change in: Stress on the aforementioned mood measures during the OMS) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).
Measured: Following one dose of treatment at 90-130 mins post-dose
Physiological stress response- Galvanic Skin Response
Modulation of the physiological response to acute stress (change in galvanic skin response) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)
Measured: Following one dose of treatment at 90-130 mins post-dose
Physiological stress response- Heart Rate
Modulation of the physiological response to acute stress (change in heart rate) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)
Measured: Following one dose of treatment at 90-130 mins post-dose
Physiological stress response- BDNF Blood Markers
Plasma levels of BDNF (brain-derived neurotrophic factor) taken pre and post-treatment
Measured: Following one dose of treatment
Physiological stress response- Adrenaline Blood Markers
Plasma levels of adrenaline taken pre and post-treatment
Measured: Following one dose of treatment
Physiological stress response- Noradrenaline Blood Markers
Plasma levels of noradrenaline taken pre and post-treatment
Measured: Following one dose of treatment
Physiological stress response- Serum Prolactin Blood Markers
Serum levels of Prolactin taken pre and post-treatment
Measured: Following one dose of treatment
Physiological stress response- α-amylase Salivary Response
Levels of α-amylase before and after acute stress (OMS)
Measured: Following one dose of treatment at 90-130 mins post-dose
Physiological stress response- Cortisol Salivary Response
Levels of salivary cortisol before and after acute stress (OMS)
Measured: Following one dose of treatment at 90-130 mins post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start4 Nov 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Balanced crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Nektium Pharma SL
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
- Investigators
- David Kennedy, Prof, Principal investigator, david.kennedy@northumbria.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299217
- Sponsor's protocol ID
- 58BX1
- Acronym
- MLE-ZYN
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Mango Leaf Extract (Zynamite®) on Cognitive Function, Mood and Physiological and Psychological Responses to Stress in Healthy Adults
- ClinicalTrials.gov ID
- NCT04299217
- Acronym / sponsor ID
- MLE-ZYN / 58BX1
- Conditions
- Cognitive Change, Stress
- Keywords
- cognition, cognitive performance, stress, nutrition, memory, attention, mental performance, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Nektium Pharma SL
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 6 Mar 2020 (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.
This study aims to assess the effects of a single dose of Zynamite® on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress.
Seventy-two healthy healthy males (50%) and females (50%) aged 18-45 years will be recruited from the general population. Participants will be randomised to receive either Zynamite® or placebo at testing visit 1, then the treatment they have not already received at testing visit 2. A single acute dose will be administered on each of the two testing visits, with at least a seven day washout period in between. The study is quantitative; participants will complete questionnaires assessing mood, cognitive tasks and an Observed Multitasking Stressor (OMS) task (with saliva samples, and blood samples for 50% of the sample). The cognitive/mood assessments will take place at baseline, then at 30, 180 and 300 minutes post-dose. The OMS assessments will take place at baseline then between 90 and 130 minutes post-dose. For participants in the bloods sub-sample, blood samples will be taken at baseline and after the 300 minute post-dose assessment. Both testing visits will be identical apart from the treatment allocated.
Detailed description
The proposed study will assess the effects of a single dose of Zynamite® on performance across a number of cognitive domains (attention, working memory, episodic memory, executive function), as well as during a period of cognitively demanding task performance, and during laboratory-induced stress. Zynamite®'s effects will also be assessed in terms of mood, and its ability to modulate the physiological and psychological response to an acute stressor.
The study will follow a randomised, double-blind, placebo-controlled, balanced cross-over design, with treatment (Zynamite®, placebo) as a factor. Seventy-two healthy males (50%) and females (50%) aged 18-45 years will be recruited using opportunity sampling. Participants will be randomised to receive either Zynamite® or placebo at testing visit 1, then the treatment they have not already received at testing visit 2. A single acute dose will be administered on each of the two testing visits, with at least a seven day washout period in between.
Testing will take place in a suite of testing facilities at the Brain, Performance and Nutrition Research Centre with participants visually isolated from each other. Participants will attend the laboratory on 3 separate occasions, an introductory visit and two testing days (Day 1 and Day 2).
Visit 1 (screening/training) The Introductory visit to the laboratory will comprise: briefing on requirements of the study, obtaining of informed consent, health screening, completion of the Caffeine Consumption Questionnaire (CCQ), training on the cognitive and mood measures and collection of demographic data.
Visit 2 Participants will attend the laboratory at a pre-arranged time in the morning having consumed a standardised breakfast of cereal and/ or toast at home no later than an hour before arrival. They must have refrained from alcohol for 24 hours and caffeine overnight. On arrival on each day participants will have a baseline rested measurement taken of their heart rate (HR) and galvanic skin response (GSR) taken, will complete the Profile of Mood States (POMS)(Mood/depression/arousal) followed by a 60 minute computerised cognitive assessment (COMPASS - including the Cognitive Demand Battery). This will be followed by completion of the Observed Multitasking Stressor (OMS) test session. This 5-10 minute OMS takes place under observation (which will include being observed by a panel and video and voice recordings) comprises provision of a saliva sample, completion of the State Trait Anxiety Inventory (STAI)-state, and visual analogue scales (VAS) which are completed before and after the stressor. The stressor comprises the performance of a verbal Serial 7s subtraction task whilst concomitantly performing a computerised tracking task. Finally a further saliva sample is taken. HR and GSR are recorded throughout. After the first cognitive/OMS assessment participants will take their treatment for the day and will undergo cognitive/mood assessments identical to the above at 30 minutes, 180 minutes and 300 minutes post-dose. The post-dose OMS assessment will take place between 90 and 130 minutes post-dose.
Blood samples will be taken from 50% of the participants both before the pre-dose, baseline assessment and after the 300 minute post-dose assessment. The two testing days (Day 1/Day2) will be identical, with the exception that participants will take a different treatment on each day.
Visit 3 (at least 7 days later) The methodology during this visit will be identical to visit 2, with the exception that participants will consume a different treatment during this visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Balanced crossover
| Arm | Type | Receives |
|---|---|---|
| Mango Leaf Extract | Active comparator | Dietary Supplement: Zynamite®300 mg Mangifera indica (mango) leaf extract standardized to ≥ 60% mangiferin (Zynamite®), plus carrier |
| Placebo | Placebo comparator | Other: PlaceboCarrier (placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must self-assess themselves as being in good health
- Aged 18 to 45 years at the time of giving consent
Key exclusion criteria (31 listed)
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled hay fever. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications 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. As above, 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, participants may be able to progress to screening.
- 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
- Are pregnant, seeking to become pregnant or lactating.
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 |
|---|---|---|
| Zynamite®Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain 60% of the polyphenol mangiferin. Zynamite® is classified as a food or food supplement and is available for purchase within the EU. Zynamite® is not associated with any significant deleterious side effects. | Dietary supplement | Mango Leaf Extract |
| PlaceboPlacebo comparator (carrier) | Other | Placebo |
Primary outcome
Mood measures- Profile of Mood States (POMS)
Time frame: Prior to (baseline) and following one dose of treatment (at 30, 180 and 300 minutes post dose)
Profile of Mood States (POMS)
Mood measures- Stress Visual Analogue Scales (VAS)
Time frame: Following one dose of treatment at 30, 180 and 300 minutes post-dose
Stress Visual Analogue Scales (VAS) (out of 100; higher score is more anxious/stressed/relaxed/calm) (pre-dose baseline and 30, 180 and 300 min post dose
Mood measures- State Trait Anxiety Inventory (STAI)
Time frame: Following one dose of treatment at 90-130 minutes post-dose
State Trait Anxiety Inventory (STAI) (20-80; higher is more anxious) (pre-OMS at baseline and 90 - 130 min post-dose).
Cognitive Function- Individual task
Time frame: Following one dose of treatment at 30, 180 and 300 min post-dose
Individual task parameters including word recall, word recognition, picture recognition, stroop, peg and ball, numeric working memory, digit vigilance, choice reaction time, simple reaction time, corsi blocks (pre-dose baseline and 30, 180 and 300 min post-dose)
Cognitive Function- Composite cognitive factors
Time frame: Following one dose of treatment at 30, 180 and 300 min post-dose
Composite cognitive factors of the aforementioned tasks e.g. Episodic memory, Working Memory, Attention, Spatial Working Memory, Executive Function, Episodic Memory (pre-dose baseline and 30, 180 and 300 min post-dose)
Cognitive Function- cognitively demanding tasks
Time frame: Following one dose of treatment at 30, 180 and 300 min post-dose
Cognitive function and mental fatigue during extended performance of cognitively demanding tasks (Cognitive Demand Battery [comprising mental arithmetic and attention tasks] (pre-dose baseline and 30, 180 and 300 min post-dose)
Cognitive Function under stressful conditions
Time frame: Following one dose of treatment at 90-130 mins post-dose
Cognitive performance (multi tasking using Serial 7s and tracking simultaneously) during acute stress as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).
Psychological stress response
Time frame: Following one dose of treatment at 90-130 mins post-dose
Modulation of the psychological response to acute stress (change in: Stress on the aforementioned mood measures during the OMS) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose).
Physiological stress response- Galvanic Skin Response
Time frame: Following one dose of treatment at 90-130 mins post-dose
Modulation of the physiological response to acute stress (change in galvanic skin response) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)
Physiological stress response- Heart Rate
Time frame: Following one dose of treatment at 90-130 mins post-dose
Modulation of the physiological response to acute stress (change in heart rate) as a consequence of the OMS (pre-dose and at 90 to 130 mins post-dose)
Physiological stress response- BDNF Blood Markers
Time frame: Following one dose of treatment
Plasma levels of BDNF (brain-derived neurotrophic factor) taken pre and post-treatment
Physiological stress response- Adrenaline Blood Markers
Time frame: Following one dose of treatment
Plasma levels of adrenaline taken pre and post-treatment
Physiological stress response- Noradrenaline Blood Markers
Time frame: Following one dose of treatment
Plasma levels of noradrenaline taken pre and post-treatment
Physiological stress response- Serum Prolactin Blood Markers
Time frame: Following one dose of treatment
Serum levels of Prolactin taken pre and post-treatment
Physiological stress response- α-amylase Salivary Response
Time frame: Following one dose of treatment at 90-130 mins post-dose
Levels of α-amylase before and after acute stress (OMS)
Physiological stress response- Cortisol Salivary Response
Time frame: Following one dose of treatment at 90-130 mins post-dose
Levels of salivary cortisol before and after acute stress (OMS)
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 11 Mar 2021.
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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.
David Kennedy, Prof principal investigator
david.kennedy@northumbria.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zynamite® in people with Cognitive Change and Stress, run by Northumbria University 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 2 inclusion and 31 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 11 Mar 2021. 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?
Mood measures- Profile of Mood States (POMS) (time frame: Prior to (baseline) and following one dose of treatment (at 30, 180 and 300 minutes post dose)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2021.