NCT03475823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

February 15, 2018

Last Update Submit

March 22, 2018

Conditions

Cognitive ChangeAffectBlood PressureNeuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cerebral Blood Flow

    Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption

  • Changes in mood

    On day 1 and following 28 days of consumption

  • Blood Pressure

    Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption

Study Arms (4)

Placebo control

PLACEBO COMPARATOR

Inert comparator indistinguishable from active interventions

Dietary Supplement: Placebo control

Active control

ACTIVE COMPARATOR

240 mg ginkgo biloba

Dietary Supplement: Ginkgo biloba

Low dose sideritis scardica

EXPERIMENTAL

475 mg sideritis scardica

Dietary Supplement: Sideritis Scardica

High dose sideritis scardica

EXPERIMENTAL

950 mg sideritis scardica

Dietary Supplement: Sideritis Scardica

Interventions

Sideritis ScardicaDIETARY_SUPPLEMENT

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

Also known as: Shepherd's tea, Olympus tea, Mountain tea
High dose sideritis scardicaLow dose sideritis scardica
Ginkgo bilobaDIETARY_SUPPLEMENT

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

Active control
Placebo controlDIETARY_SUPPLEMENT

An inert encapsulated powder provided by Finzelberg.

Placebo control

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age
  • No underlying health problem which would prevent engagement with the study

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Performance and Nutrition Research centre

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

Location

MeSH Terms

Interventions

Ginkgo Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Emma L Wightman, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 23, 2018

Study Start

February 17, 2017

Primary Completion

September 18, 2017

Study Completion

September 18, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

GB(1)