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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 mg sage/polyphenol combination | Active Comparator | 600 mg of this sage/polyphenol combination will be consumed, via capsule, per day for 29 days. |
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| Placebo | Placebo Comparator | The same number of aesthetically similar capsules will be consumed per day for 29 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognivia | Dietary Supplement | Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute change in global cognitive task performance | 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. | 120 minutes and 240 minutes post dose on day 1 of treatment supplementation |
| Acute changes in mood; as assessed by the Bond-Lader mood scales | 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. | 120 minutes and 240 minutes post dose on day 1 of treatment supplementation |
| Interim changes in global cognitive task performance | 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. | Day 7, day 14, day 21 and day 28 |
| Chronic changes in cognitive task performance | 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. | Pre-dose, 120 minutes and 240 minutes post-dose on day 29 of treatment supplementation |
| Chronic changes in mood; as assessed by the Bond-Lader mood scales |
| Measure | Description | Time Frame |
|---|---|---|
| Acute changes in blood pressure | 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. | 120 minutes and 240 minutes post dose on day 1 of treatment supplementation |
| Chronic changes in blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Wightman, Dr | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Performance and Nutrition Research Centre | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
The IPD will be shared among the named investigators and Nexira only.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2018 | Sep 28, 2018 | Prot_000.pdf |
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The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.
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Double blind. Randomized by a disinterested third party. Placebo and active capsules matched for aesthetics.
| Placebo | Dietary Supplement | Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules |
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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. |
| Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation |
| Change in prospective memory performance; as assessed by a prospective memory task (the prospective remembering video task) | 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. | Day 25 and day 29 |
| Acute changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI) | 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. | 120 minutes and 240 minutes post dose on day 29 of treatment supplementation |
| Chronic changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI) | 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. | 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. |
| Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation |
| Acute changes in heart rate | Changes in heart rate (HR) as compared to pre-dose HR on day 1. HR is assessed via forearm cuff. | 120 minutes and 240 minutes post dose on day 1 of treatment supplementation |
| Chronic changes in heart rate | Changes in heart rate (HR) as compared to pre-dose HR on day 1. HR is assessed via forearm cuff. | Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation |