Cognitive and Blood Flow Effects of Mountain Tea

NCT ID: NCT03475823

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2017-09-18

Brief Summary

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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

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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.

Conditions

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Cognitive Change Affect Blood Pressure Neuroimaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.

Study Groups

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Placebo control

Inert comparator indistinguishable from active interventions

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

An inert encapsulated powder provided by Finzelberg.

Active control

240 mg ginkgo biloba

Group Type ACTIVE_COMPARATOR

Ginkgo biloba

Intervention Type DIETARY_SUPPLEMENT

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

Low dose sideritis scardica

475 mg sideritis scardica

Group Type EXPERIMENTAL

Sideritis Scardica

Intervention Type DIETARY_SUPPLEMENT

Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant

High dose sideritis scardica

950 mg sideritis scardica

Group Type EXPERIMENTAL

Sideritis Scardica

Intervention Type DIETARY_SUPPLEMENT

Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant

Interventions

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Sideritis Scardica

Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Placebo control

An inert encapsulated powder provided by Finzelberg.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Shepherd's tea Olympus tea Mountain tea

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Finzelberg

UNKNOWN

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Emma Wightman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma L Wightman, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Brain Performance and Nutrition Research centre

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SUB010_Khan_141116

Identifier Type: -

Identifier Source: org_study_id

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