Cognitive ChangeNCT03475823
Cognitive and Blood Flow Effects of Mountain Tea
A study testing Sideritis Scardica and Ginkgo biloba in people with Cognitive Change and Affect, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of 50-70 yr olds, both acutely and following 28 days of consumption. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Affect, Blood Pressure
- What is being tested?
- Sideritis Scardica and Ginkgo biloba
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2017to 18 Sep 2017
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-70 yrs of age
- No underlying health problem which would prevent engagement with the study
Who cannot join
- BMI < 18 or > 35 kg/m2
- High blood pressure (defined as systolic > 159 mmHg or diastolic > 90 mmHg)
- Smoking
- Food allergies or insensitivities
- Pregnancy or breast feeding
- Currently taking any medication (use of contraceptives/hormone replacements was not excluded) or dietary supplements which would contraindicate with the study
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- Sleep disturbances and/or taking sleep aid medication
- History of neurological, vascular or psychiatric illness
- Current diagnosis of anxiety or depression
- Migraines
- Recent history (within 12 months) of alcohol/substance abuse
- Disorder of the blood
- Heart disorder/history of vascular illness
- Respiratory disorder requiring regular medication
- Type I or II diabetes
- Renal disease, hepatic disease or severe disease of the gastrointestinal tract - Any health condition that would prevent the fulfilment of the study requirements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain Performance and Nutrition Research centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of a Sideritis Scardica (Mountain Tea) Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of 50-70 yr olds, both acutely and following 28 days of consumption.
Read the detailed description
The presence of polyphenols such as ferulic acid, chlorogenic acid and apigenin in Sideritis Scardica (SS or 'mountain tea') are likely responsible for the cognitive and mood effects of its consumption and this could be underpinned by the ability of such polyphenols to prevent monoamine neurotransmitter reuptake and to increase cerebral blood flow (CBF).
The current randomised, placebo controlled, parallel groups study extends on the abovementioned small amount of literature; assessing both cognitive and mood outcomes in a sample of older (50-70 yrs) adults, as well as blood pressure (BP) and CBF, in a sub-sample, utilizing near-infrared spectroscopy (NIRS). The above will be assessed acutely (pre-dose and 90- and 310-mins post dose) on day 1 and following 28 days consumption of either a placebo control, and active control of 240 mg ginkgo biloba, 475 mg SS or 950 mg SS.
- Conditions
- Cognitive Change, Affect, Blood Pressure, Neuroimaging
- Being tested
- Sideritis Scardica, Ginkgo biloba, Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sideritis ScardicaDietary supplement
Also called Shepherd's tea, Olympus tea, Mountain tea
Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant
Ginkgo bilobaDietary supplement
Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
Placebo controlDietary supplement
An inert encapsulated powder provided by Finzelberg.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | Inert comparator indistinguishable from active interventions Receives: Dietary Supplement: Placebo control |
| Active control | Active comparator | 240 mg ginkgo biloba Receives: Dietary Supplement: Ginkgo biloba |
| Low dose sideritis scardica | Experimental | 475 mg sideritis scardica Receives: Dietary Supplement: Sideritis Scardica |
| High dose sideritis scardica | Experimental | 950 mg sideritis scardica Receives: Dietary Supplement: Sideritis Scardica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognition
Acute and chronic change in cognitive function via the following cognitive tasks: numeric working memory, choice reaction time, corsi blocks, serial 3 and 7 subtractions, rapid visual information processing, peg and ball, name to face recall, picture recognition, word recognition, immediate word recall and delayed word recall. All tasks provide an outcome for accuracy, speed and error.
Measured: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Secondary outcomes (3)
Cerebral Blood Flow
Blood flow changes measured in the pre-frontal cortex utilizing Near-Infrared Spectroscopy (NIRS). Outcome measures include; oxygen saturation, oxygenated haemoglobin, deoxygenated haemoglobin and total haemoglobin.
Measured: Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption
Changes in mood
Acute and chronic changes in mood as assessed by the State-Trait anxiety Inventory (Spielberger, 1983) and Bond-Lader (1974) visual analogue scales. For both measures a baseline score is calculated and all subsequent post-dose scores are subtracted from this to produce change (change from baseline) scores. Both the STAI and Bond-Lader scales produce numerical values and the outcome measure for both will be the same; i.e. changes in this numerical value from baseline mood.
Measured: On day 1 and following 28 days of consumption
Blood Pressure
Acute and chronic changes in blood pressure.
Measured: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start17 Feb 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Finzelberg
- Responsible party
- Principal investigator, Emma Wightman, Northumbria University
- Investigators
- Emma L Wightman, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475823
- Sponsor's protocol ID
- SUB010_Khan_141116
- Status last verified
- Mar 2018
- First submitted
- 15 Feb 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of a Sideritis Scardica (Mountain Tea) Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
- ClinicalTrials.gov ID
- NCT03475823
- Acronym / sponsor ID
- SUB010_Khan_141116
- Conditions
- Cognitive Change, Affect, Blood Pressure, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Finzelberg
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 23 Mar 2018 (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.
Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of 50-70 yr olds, both acutely and following 28 days of consumption.
Detailed description
The presence of polyphenols such as ferulic acid, chlorogenic acid and apigenin in Sideritis Scardica (SS or 'mountain tea') are likely responsible for the cognitive and mood effects of its consumption and this could be underpinned by the ability of such polyphenols to prevent monoamine neurotransmitter reuptake and to increase cerebral blood flow (CBF).
The current randomised, placebo controlled, parallel groups study extends on the abovementioned small amount of literature; assessing both cognitive and mood outcomes in a sample of older (50-70 yrs) adults, as well as blood pressure (BP) and CBF, in a sub-sample, utilizing near-infrared spectroscopy (NIRS). The above will be assessed acutely (pre-dose and 90- and 310-mins post dose) on day 1 and following 28 days consumption of either a placebo control, and active control of 240 mg ginkgo biloba, 475 mg SS or 950 mg SS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Dietary Supplement: Placebo controlInert comparator indistinguishable from active interventions |
| Active control | Active comparator | Dietary Supplement: Ginkgo biloba240 mg ginkgo biloba |
| Low dose sideritis scardica | Experimental | Dietary Supplement: Sideritis Scardica475 mg sideritis scardica |
| High dose sideritis scardica | Experimental | Dietary Supplement: Sideritis Scardica950 mg sideritis scardica |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-70 yrs of age
- No underlying health problem which would prevent engagement with the study
Key exclusion criteria (16 listed)
- BMI < 18 or > 35 kg/m2
- High blood pressure (defined as systolic > 159 mmHg or diastolic > 90 mmHg)
- Smoking
- Food allergies or insensitivities
- Pregnancy or breast feeding
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 |
|---|---|---|
| Sideritis ScardicaAlso: Shepherd's tea, Olympus tea, Mountain teaSideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant | Dietary supplement | High dose sideritis scardica, Low dose sideritis scardica |
| Ginkgo bilobaGinkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control. | Dietary supplement | Active control |
| Placebo controlAn inert encapsulated powder provided by Finzelberg. | Dietary supplement | Placebo control |
Primary outcome
Changes in cognition
Time frame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Acute and chronic change in cognitive function via the following cognitive tasks: numeric working memory, choice reaction time, corsi blocks, serial 3 and 7 subtractions, rapid visual information processing, peg and ball, name to face recall, picture recognition, word recognition, immediate word recall and delayed word recall. All tasks provide an outcome for accuracy, speed and error.
3 secondary outcomes
Cerebral Blood Flow
Time frame: Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption
Changes in mood
Time frame: On day 1 and following 28 days of consumption
Blood Pressure
Time frame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
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 23 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Emma L Wightman, PhD 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 Sideritis Scardica and Ginkgo biloba in people with Cognitive Change and Affect, 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 16 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 23 Mar 2018. 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?
Changes in cognition (time frame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption). 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 23 Mar 2018.