Clinical trial NCT03695003: Cognitive Effects of Sage in Healthy Humans
Official title: The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Mood Change
Keywords: Sage
Terpene
Polyphenol
Cognition
Mood
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 94
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.
Primary purpose: OTHER

Brief summary: Extracts of sage and polyphenols have separately been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has combined these interventions. The current study investigates the effects of this combined intervention in N=90 healthy males and females between 30-60 yrs, at 600 mg versus placebo, on cognition and mood over a 29 day period.

Detailed description: Improved cognitive performance has been observed in humans following supplementation of sage extracts; including recall and mental arithmetic ability. Aspects of mood have also shown improvements; e.g. increased alertness, calmness and contentedness and reduced mental fatigue. These effects are believed to be underpinned by interactions with cholinergic and GABA pathways. Polyphenols too have shown promise in boosting cognition and mood and interaction with vasodilatory pathways and GABA neurotransmission are purported to be the likely mechanisms involved. Research has yet to investigate if a combination of sage terpenes and polyphenols could be even more efficacious via synergistic interaction.The current study investigates the effects of a 600 mg sage/polyphenol combination on cognition and mood in N=90 healthy male and female participants between the ages of 30-60 yrs acutely; on day 1 of supplementation, and chronically; after 29 days. Cognitive and mood data will also be collected every 7 days in the interim via a mobile phone cognitive task battery.

Eligibility criteria: Inclusion Criteria:

* Participants must self-assess themselves as being in good health.
* Aged 30 to 60 years at the time of giving consent
* In daytime employment and/or higher education

Exclusion Criteria:

* Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
* Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening.
* Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
* Are pregnant, seeking to become pregnant or lactating
* Have learning and/or behavioural difficulties such as dyslexia or ADHD
* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
* Smoker
* excessive caffeine intake (\>500 mg per day)
* Have food intolerances/ sensitivities
* Have taken antibiotics, prebiotics or probiotics (including drinks. Eg. Yakult or Actimel) within the past 8 weeks
* Have any health condition that would prevent fulfillment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
* Are unable to complete all of the study assessments
* Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
* Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
* Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
* Suffers from frequent migraines that require medication (more than or equal to 1 per month)
* Sleep disturbances (including night-shift work) and/ or are taking sleep aid medication
* Any known active infections
* Does not have a bank account (required for payment)
* Are non-compliant with regards treatment consumption (see 4.3)

Primary outcomes:
measure: Acute change in global cognitive task performance
timeFrame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
measure: Acute changes in mood; as assessed by the Bond-Lader mood scales
timeFrame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
measure: Interim changes in global cognitive task performance
timeFrame: Day 7, day 14, day 21 and day 28
measure: Chronic changes in cognitive task performance
timeFrame: Pre-dose, 120 minutes and 240 minutes post-dose on day 29 of treatment supplementation
measure: Chronic changes in mood; as assessed by the Bond-Lader mood scales
timeFrame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
measure: Change in prospective memory performance; as assessed by a prospective memory task (the prospective remembering video task)
timeFrame: Day 25 and day 29
measure: Acute changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)
timeFrame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
measure: Chronic changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)
timeFrame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Secondary outcomes:
measure: Acute changes in blood pressure
timeFrame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
measure: Chronic changes in blood pressure
timeFrame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
measure: Acute changes in heart rate
timeFrame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
measure: Chronic changes in heart rate
timeFrame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain Performance and Nutrition Research Centre
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Emma Wightman, Dr
role: PRINCIPAL_INVESTIGATOR
References: