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Completed

NCT Number: NCT03475823

Cognitive and Blood Flow Effects of Mountain Tea

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Performance and Nutrition Research centre

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sideritis Scardica

Dietary Supplement

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

Ginkgo biloba

Dietary Supplement

Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.

Placebo Control

Dietary Supplement

An inert encapsulated powder provided by Finzelberg.

Primary outcomes

  1. Changes in cognition

    Time frame: 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 outcomes

  1. Cerebral Blood Flow

    Time frame: 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.

  2. Changes in mood

    Time frame: 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.

  3. Blood Pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Finzelberg

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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