Cognitive and Blood Flow Effects of Mountain Tea
- Conditions
- AffectCognitive ChangeBlood PressureNeuroimaging
- Interventions
- Dietary Supplement: Placebo controlDietary Supplement: Sideritis ScardicaDietary Supplement: Ginkgo biloba
- Registration Number
- NCT03475823
- Lead Sponsor
- Northumbria University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- 50-70 yrs of age
- No underlying health problem which would prevent engagement with the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo control Placebo control Inert comparator indistinguishable from active interventions High dose sideritis scardica Sideritis Scardica 950 mg sideritis scardica Low dose sideritis scardica Sideritis Scardica 475 mg sideritis scardica Active control Ginkgo biloba 240 mg ginkgo biloba
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Brain Performance and Nutrition Research centre
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom