Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive and Blood Flow Effects of Mountain Tea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475823
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
Finzelberg
Information provided by (Responsible Party):
Emma Wightman, Northumbria University

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
Cognitive Change Affect Blood Pressure Neuroimaging Dietary Supplement: Sideritis Scardica Dietary Supplement: Ginkgo biloba Dietary Supplement: Placebo control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 17, 2017
Actual Primary Completion Date : September 18, 2017
Actual Study Completion Date : September 18, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475823


Locations
Layout table for location information
United Kingdom
Brain Performance and Nutrition Research centre
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Finzelberg
Investigators
Layout table for investigator information
Principal Investigator: Emma L Wightman, PhD Northumbria University
Layout table for additonal information
Responsible Party: Emma Wightman, Principal investigator, Northumbria University
ClinicalTrials.gov Identifier: NCT03475823    
Other Study ID Numbers: SUB010_Khan_141116
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No