HealthyNCT01605682
Multi Dose Effects of a Berry Extract Upon Moodand Cognition in Healthy Young Adults
A study testing Fresh berry extract. in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fresh berry extract.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Feb 2012
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- aged between 18-35 years old,
- non smokers,
- bmi < 30kg/m2
Who cannot join
- smoker,
- pregnant,
- currently taking recreational over the counter/prescription medication (excluding the contraceptive pill) and/or dietary/herbal supplements.
- food allergies or sensitivities that are relevant to the study,
- learning difficulties,
- ADHD,
Show all 9Show fewer
- dyslexia,
- migraines or
- any gastric problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Brain Performance and Nutrition Research Center
Newcastle upon Tyne, NE21 8ST
About this study
Official title: Multi Dose Effects of a Berry Extract Upon Mood, Attention and Memory in Healthy Young Adults.
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties.
Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life.
Read more
A prior study carried out as the first study of my PhD, attempted to bridge this gap in knowledge and found promising results after acutely supplementing participants with a fruit based drink. The findings showed that there was an increased vigilance on attention related psychometric tasks and an increased feeling of calmness. The investigators have hypothesised that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B activity.
The aims of the current study are threefold: to extend the findings of my previous investigation by extending the tasks explored; to ascertain if the positive results of the first study are dose dependent; and to investigate whether a lower dose can facilitate greater changes in behaviour.
Read the detailed description
The project will investigate the acute effects on human cognitive behaviour and mood of a single consumption of 3 fruit drinks versus a placebo. Drinks will be matched for volume, taste, appearance and sugars but will differ in the amount of total polyphenols. The 3 active treatment drinks contain a natural berry fruit grown in New Zealand by Plant and Food Research from commercial cultivars.
The study will follow a double-blind, counterbalanced, placebo controlled, repeated measures, crossover design with 36 healthy participants aged between 18 and 35 completing four study day sessions as well as one training/screening visit (five visits in total). On one occasion participants will receive a placebo, on another fruit drink 1, on another fruit drink 2 and on another fruit drink 3. Study days will be spaced one week apart to accommodate a wash out period. Fruit drinks will be made to include 500mg, 250mg or 125mg of polyphenols/60kg of body weight. Sucralose (artificial sweetener) will be added to make the drinks palatable. Participants will be screened for any intolerance or allergies to the drinks during the training/screening session . Trait anxiety will also be assessed during the screening visit using the State-Trait Anxiety inventory (STAI - Spielberger, 1966).
Psychometric tasks and mood scales will be delivered using the Computerised Mental Performance Assessment System (COMPASS), a purpose designed software application for the flexible delivery of randomly generated parallel versions of standard and novel cognitive assessment tasks that has previously been shown to be sensitive to nutritional interventions. .
Baseline cognitive testing will involve the dual task, Digit vigilance, Digit vigilance fast, Visual analogue scales, 3-back, corsi blocks, simple reaction time, telephone number task, word recognition, word recall, Bond-Lader mood scales and the state anxiety questionnaire (STAI).
Baseline On all 3 testing days participants will arrive at the lab in the morning (8:00 am), after an overnight fast, and firstly give a 10 mL venous blood sample taken by a trained phlebotomist. Participants will then complete one repetition of the COMPASS computerised cognitive assessment battery (baseline). Participants will then be orally supplemented with treatment in the form of a single serve juice drink (200ml per 60kg weight).
Post Supplementation 60 minutes after supplementation, the first post dose state anxiety questionnaire will be completed. Participants will then complete the first post dose COMPASS assessment. After completion of the assessment participants will immediately give a second 10 ml venous blood sample. Participants will then have a 20 minute break before completing the second post dose COMPASS assessment and complete a final post dose state anxiety questionnaire.
- Conditions
- Healthy
- Being tested
- Fresh berry extract.
- Keywords
- effect of different berry doses on mood and cognition, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh berry extract.Dietary supplement
Fresh berry extract containing 500mg, 250mg, 125mg per 60 kilos of body weight. Or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Berry extract 125 | Experimental | Fresh berry extract containing 125mg of polyphenols Receives: Dietary Supplement: Fresh berry extract. |
| Berry extract 250 | Experimental | Fresh berry extract containing 250mg of polyphenols Receives: Dietary Supplement: Fresh berry extract. |
| Berry extract 500 | Experimental | Fresh berry extract containing 500mg of polyphenols Receives: Dietary Supplement: Fresh berry extract. |
| Placebo | Placebo comparator | Berry flavoured juice containing no polyphenols Receives: Dietary Supplement: Fresh berry extract. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognition
Measured: baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in mood
Measured: Baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in Monoamine Oxidase-B activity
Measured: baseline and 2 hours post dose
Secondary outcomes (1)
Change in prolactin
Measured: baseline and 2 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Responsible party
- Sponsor
- Investigators
- Anthony w Watson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605682
- Sponsor's protocol ID
- 28AI2
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Dose Effects of a Berry Extract Upon Mood, Attention and Memory in Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT01605682
- Acronym / sponsor ID
- 28AI2
- Conditions
- Healthy
- Keywords
- effect of different berry doses on mood and cognition, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 May 2012 (estimated)
- 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.
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties.
Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life.
A prior study carried out as the first study of my PhD, attempted to bridge this gap in knowledge and found promising results after acutely supplementing participants with a fruit based drink. The findings showed that there was an increased vigilance on attention related psychometric tasks and an increased feeling of calmness. The investigators have hypothesised that these cognitive enhancing effects are due to the monoamine oxidase (MAO) inhibiting effect of the fruit drink, our ex vivo findings support this with a 96% reduction in MAO-B activity.
The aims of the current study are threefold: to extend the findings of my previous investigation by extending the tasks explored; to ascertain if the positive results of the first study are dose dependent; and to investigate whether a lower dose can facilitate greater changes in behaviour.
Detailed description
The project will investigate the acute effects on human cognitive behaviour and mood of a single consumption of 3 fruit drinks versus a placebo. Drinks will be matched for volume, taste, appearance and sugars but will differ in the amount of total polyphenols. The 3 active treatment drinks contain a natural berry fruit grown in New Zealand by Plant and Food Research from commercial cultivars.
The study will follow a double-blind, counterbalanced, placebo controlled, repeated measures, crossover design with 36 healthy participants aged between 18 and 35 completing four study day sessions as well as one training/screening visit (five visits in total). On one occasion participants will receive a placebo, on another fruit drink 1, on another fruit drink 2 and on another fruit drink 3. Study days will be spaced one week apart to accommodate a wash out period. Fruit drinks will be made to include 500mg, 250mg or 125mg of polyphenols/60kg of body weight. Sucralose (artificial sweetener) will be added to make the drinks palatable. Participants will be screened for any intolerance or allergies to the drinks during the training/screening session . Trait anxiety will also be assessed during the screening visit using the State-Trait Anxiety inventory (STAI - Spielberger, 1966).
Psychometric tasks and mood scales will be delivered using the Computerised Mental Performance Assessment System (COMPASS), a purpose designed software application for the flexible delivery of randomly generated parallel versions of standard and novel cognitive assessment tasks that has previously been shown to be sensitive to nutritional interventions. .
Baseline cognitive testing will involve the dual task, Digit vigilance, Digit vigilance fast, Visual analogue scales, 3-back, corsi blocks, simple reaction time, telephone number task, word recognition, word recall, Bond-Lader mood scales and the state anxiety questionnaire (STAI).
Baseline On all 3 testing days participants will arrive at the lab in the morning (8:00 am), after an overnight fast, and firstly give a 10 mL venous blood sample taken by a trained phlebotomist. Participants will then complete one repetition of the COMPASS computerised cognitive assessment battery (baseline). Participants will then be orally supplemented with treatment in the form of a single serve juice drink (200ml per 60kg weight).
Post Supplementation 60 minutes after supplementation, the first post dose state anxiety questionnaire will be completed. Participants will then complete the first post dose COMPASS assessment. After completion of the assessment participants will immediately give a second 10 ml venous blood sample. Participants will then have a 20 minute break before completing the second post dose COMPASS assessment and complete a final post dose state anxiety questionnaire.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Berry extract 125 | Experimental | Dietary Supplement: Fresh berry extract.Fresh berry extract containing 125mg of polyphenols |
| Berry extract 250 | Experimental | Dietary Supplement: Fresh berry extract.Fresh berry extract containing 250mg of polyphenols |
| Berry extract 500 | Experimental | Dietary Supplement: Fresh berry extract.Fresh berry extract containing 500mg of polyphenols |
| Placebo | Placebo comparator | Dietary Supplement: Fresh berry extract.Berry flavoured juice containing no polyphenols |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- aged between 18-35 years old,
- non smokers,
- bmi < 30kg/m2
Key exclusion criteria (9 listed)
- smoker,
- pregnant,
- currently taking recreational over the counter/prescription medication (excluding the contraceptive pill) and/or dietary/herbal supplements.
- food allergies or sensitivities that are relevant to the study,
- learning difficulties,
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 |
|---|---|---|
| Fresh berry extract.Fresh berry extract containing 500mg, 250mg, 125mg per 60 kilos of body weight. Or placebo. | Dietary supplement | Berry extract 125, Berry extract 250, Berry extract 500, Placebo |
Primary outcome
Change in cognition
Time frame: baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in mood
Time frame: Baseline, 1 hour post dose and 2 hours 30mins post dose.
Change in Monoamine Oxidase-B activity
Time frame: baseline and 2 hours post dose
1 secondary outcome
Change in prolactin
Time frame: baseline and 2 hours post dose
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 25 May 2012.
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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.
Anthony w Watson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh berry extract. in people with Healthy, 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 4 inclusion and 9 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 25 May 2012. 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?
Change in cognition (time frame: baseline, 1 hour post dose and 2 hours 30mins post dose.). The study lists 3 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 25 May 2012.