Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Finzelberg | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Placebo Comparator | Inert comparator indistinguishable from active interventions |
|
| Active control | Active Comparator | 240 mg ginkgo biloba |
|
| Low dose sideritis scardica | Experimental | 475 mg sideritis scardica |
|
| High dose sideritis scardica | Experimental | 950 mg sideritis scardica |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sideritis Scardica | Dietary Supplement | Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Blood Flow | 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. | Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emma L Wightman, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Performance and Nutrition Research centre | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2020 | |
| Reset | Mar 20, 2020 | |
| Release | Aug 31, 2021 | |
| Reset | Sep 27, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2020 | Mar 20, 2020 | |||
| Aug 31, 2021 |
| ID | Term |
|---|---|
| D000096983 | Ginkgo Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.
|
| 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. |
|
| Changes in mood |
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. |
| On day 1 and following 28 days of consumption |
| Blood Pressure | Acute and chronic changes in blood pressure. | Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption |
| Sep 27, 2021 |