Cognitive and Blood Flow Effects of Mountain Tea

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Affect, Cognitive Change, Blood Pressure, Neuroimaging

Intervention / Treatment
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* Dietary Supplement: Sideritis Scardica
* Dietary Supplement: Ginkgo biloba
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50-70 yrs of age No underlying health problem which would prevent engagement with the study Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control<br>Inert comparator indistinguishable from active interventions | Dietary Supplement: Placebo control<br>* An inert encapsulated powder provided by Finzelberg.<br>|
| Active Comparator: Active control<br>240 mg ginkgo biloba | Dietary Supplement: Ginkgo biloba<br>* Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.<br>|
| Experimental: Low dose sideritis scardica<br>475 mg sideritis scardica | Dietary Supplement: Sideritis Scardica<br>* Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant<br>* Other names: Mountain tea;|
| Experimental: High dose sideritis scardica<br>950 mg sideritis scardica | Dietary Supplement: Sideritis Scardica<br>* Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant<br>* Other names: Mountain tea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | On day 1 and following 28 days of consumption | 
| Blood Pressure | Acute and chronic changes in blood pressure. | Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption |