Cognitive and Blood Flow Effects of Mountain Tea

Northumbria University

Status: Completed

Conditions: Cognitive Change; Neuroimaging; Affect; Blood Pressure

Treatments: Dietary Supplement: Sideritis Scardica; Dietary Supplement: Placebo control; Dietary Supplement: Ginkgo biloba

Study type: Interventional

Funder types: Other

Identifiers

NCT03475823

SUB010_Khan_141116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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155 participants in 4 patient groups, including a placebo group

Placebo control

Placebo Comparator group

Description:

Inert comparator indistinguishable from active interventions

Treatment:

Dietary Supplement: Placebo control

Active control

Active Comparator group

Description:

240 mg ginkgo biloba

Treatment:

Dietary Supplement: Ginkgo biloba

Low dose sideritis scardica

Experimental group

Description:

475 mg sideritis scardica

Treatment:

Dietary Supplement: Sideritis Scardica

High dose sideritis scardica

Experimental group

Description:

950 mg sideritis scardica

Treatment:

Dietary Supplement: Sideritis Scardica