Cognitive Change, Affect, Blood Pressure, Neuroimaging
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTSideritis Scardica
Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant
DIETARY_SUPPLEMENTGinkgo biloba
Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
DIETARY_SUPPLEMENTPlacebo control
An inert encapsulated powder provided by Finzelberg.
Sponsors
Finzelberg
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cognition | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood Flow | Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption | 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. |
| Changes in mood | On day 1 and following 28 days of consumption | 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. |
| Blood Pressure | Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption | Acute and chronic changes in blood pressure. |
Countries
United Kingdom
Outcome results
None listed