Clinical trial NCT03475823: Cognitive and Blood Flow Effects of Mountain Tea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Affect
Blood Pressure
Neuroimaging
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Finzelberg
First posted: 2018-03-23
Enrollment: 155
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in cognition
timeFrame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Secondary outcomes:
measure: Cerebral Blood Flow
timeFrame: Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption
measure: Changes in mood
timeFrame: On day 1 and following 28 days of consumption
measure: Blood Pressure
timeFrame: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain Performance and Nutrition Research centre
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Emma L Wightman, PhD
role: PRINCIPAL_INVESTIGATOR
References: