Brain Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
NCT Number: NCT03695003
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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Notify Me30 year–60 year
All sexes
Interventional
Not applicable
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira
Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Northumbria University
Other
The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study in Healthy Humans
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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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