Cognitive and Blood Flow Effects of Mountain Tea

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475823
• Other study ID #: SUB010_Khan_141116
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: March 22, 2018
• Start date: February 17, 2017
• Est. completion date: September 18, 2017

Study information

• Verified date: March 2018
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Affect
• Blood Pressure
• Cognitive Change
• Neuroimaging

Intervention

Dietary Supplement:
• Sideritis Scardica
Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant
• Ginkgo biloba
Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
• Placebo control
An inert encapsulated powder provided by Finzelberg.

Locations

Country	Name	City	State
United Kingdom	Brain Performance and Nutrition Research centre	Newcastle Upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Finzelberg

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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