Blood Pressure Clinical Trial
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
Verified date | March 2018 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 155 |
Est. completion date | September 18, 2017 |
Est. primary completion date | September 18, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Brain Performance and Nutrition Research centre | Newcastle Upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | Finzelberg |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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