An interventional study of Sideritis Scardica and Ginkgo biloba in Cognitive Change, Affect and Blood Pressure, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Northumbria University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Inert comparator indistinguishable from active interventions
Dietary Supplement: Placebo control
240 mg ginkgo biloba
Dietary Supplement: Ginkgo biloba
475 mg sideritis scardica
Dietary Supplement: Sideritis Scardica
950 mg sideritis scardica
Dietary Supplement: Sideritis Scardica
Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant
Also known as: Shepherd's tea, Olympus tea, Mountain tea
Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
An inert encapsulated powder provided by Finzelberg.
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.
Time frame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
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.
Time frame: 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.
Time frame: On day 1 and following 28 days of consumption
Blood Pressure
Acute and chronic changes in blood pressure.
Time frame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Plan to share: Undecided
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Northumbria University