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Cognitive and Blood Flow Effects of Mountain Tea

Sponsor
Northumbria University (Other)
Overall Status
Completed
CT.gov ID
NCT03475823
Collaborator
Finzelberg (Other)
155
Enrollment
1
Location
4
Arms
7
Actual Duration (Months)
22.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Sideritis Scardica
  • Dietary Supplement: Ginkgo biloba
  • Dietary Supplement: Placebo control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.
Primary Purpose:
Other
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
Actual Study Start Date :
Feb 17, 2017
Actual Primary Completion Date :
Sep 18, 2017
Actual Study Completion Date :
Sep 18, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brain Performance and Nutrition Research centre Newcastle Upon Tyne Tyne And Wear United Kingdom NE1 8ST

    Sponsors and Collaborators

    • Northumbria University
    • Finzelberg

    Investigators

    • Principal Investigator: Emma L Wightman, PhD, Northumbria University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emma Wightman, Principal investigator, Northumbria University
    ClinicalTrials.gov Identifier:
    NCT03475823
    Other Study ID Numbers:
    • SUB010_Khan_141116
    First Posted:
    Mar 23, 2018
    Last Update Posted:
    Mar 23, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 23, 2018