Cognitive and Blood Flow Effects of Mountain Tea

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Blood Pressure; Affect; Neuroimaging
• Intervention / Treatment: Dietary supplement: Placebo control; Dietary supplement: Ginkgo biloba; Dietary supplement: Sideritis Scardica

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
      • Brain Performance and Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control; Inert comparator indistinguishable from active interventions	Dietary supplement: Placebo control; An inert encapsulated powder provided by Finzelberg.
Active Comparator: Active control; 240 mg ginkgo biloba	Dietary supplement: Ginkgo biloba; Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
Experimental: Low dose sideritis scardica; 475 mg sideritis scardica	Dietary supplement: Sideritis Scardica; Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant; Other Names: Shepherd's tea; Olympus tea; Mountain tea
Experimental: High dose 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; Other Names: Shepherd's tea; Olympus tea; Mountain tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Finzelberg
• Investigators: Principal Investigator: Emma L Wightman, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 18, 2017

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SUB010_Khan_141116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No