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Completed

NCT Number: NCT03695003

Cognitive Effects of Sage in Healthy Humans

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognivia

Dietary Supplement

Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira

Placebo

Dietary Supplement

Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules

Primary outcomes

  1. Acute change in global cognitive task performance

    Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation

    Changes in executive function, working memory, spatial memory, secondary memory and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.

  2. Acute changes in mood; as assessed by the Bond-Lader mood scales

    Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation

    The Bond-Lader mood visual analogue scales will be used at baseline and 120- and 240-minutes post dose on day 1. The derived scores on alertness, calmness and contentedness will be 'changed-from-baseline' and this score compared across the treatments.

  3. Interim changes in global cognitive task performance

    Time frame: Day 7, day 14, day 21 and day 28

    Changes in attention, executive function, working memory and episodic memory as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.

  4. Chronic changes in cognitive task performance

    Time frame: Pre-dose, 120 minutes and 240 minutes post-dose on day 29 of treatment supplementation

    Changes in executive function, working memory, spatial memory, secondary memory and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains.

  5. Chronic changes in mood; as assessed by the Bond-Lader mood scales

    Time frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation

    The Bond-Lader mood visual analogue scales will be used at baseline and 120- and 240-minutes post dose on day 29. The derived scores on alertness, calmness and contentedness will be 'changed-from-baseline' and this score compared across the treatments.

  6. Change in prospective memory performance; as assessed by a prospective memory task (the prospective remembering video task)

    Time frame: Day 25 and day 29

    This individual task is called the Prospective Remembering Video Task (PRVP) and requires participants to remember a list of remembered locations and actions and identify these as they watch a video with them unfolding. The task is scored for difference in prospective memory/location learning performance between active and placebo on day 25 of supplementation period and also the difference in amount of memory decay of prospective memory/location learning on day 29 of treatment supplementation.

  7. Acute changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)

    Time frame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation

    The STAI will be used at baseline and 120- and 240-minutes post dose on day 1. The anxiety scores will be 'changed-from-baseline' and this score compared across the treatments.

  8. Chronic changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)

    Time frame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation

    The STAI will be used at baseline and 120- and 240-minutes post dose on day 29. The anxiety scores will be 'changed-from-baseline' and this score compared across the treatments.

Secondary outcomes

  1. Acute changes in blood pressure

    Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation

    Changes in blood pressure (BP) as compared to pre-dose BP on day 1. BP is assessed via forearm cuff and provides systolic and diastolic BP.

  2. Chronic changes in blood pressure

    Time frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation

    Changes in blood pressure (BP) as compared to pre-dose BP on day 1. BP is assessed via forearm cuff and provides systolic and diastolic BP.

  3. Acute changes in heart rate

    Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation

    Changes in heart rate (HR) as compared to pre-dose HR on day 1. HR is assessed via forearm cuff.

  4. Chronic changes in heart rate

    Time frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation

    Changes in heart rate (HR) as compared to pre-dose HR on day 1. HR is assessed via forearm cuff.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study title

The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study in Healthy Humans

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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