Cognitive ChangeNCT03695003
Cognitive Effects of Sage in Healthy Humans
A study testing Cognivia in people with Cognitive Change and Mood Change, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood Change
- What is being tested?
- Cognivia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study 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.
Read the 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.
- Conditions
- Cognitive Change, Mood Change
- Being tested
- Cognivia, Placebo
- Keywords
- Sage, Terpene, Polyphenol, Cognition, Mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogniviaDietary supplement
Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira
PlaceboDietary supplement
Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules
| Study group | Role | What they receive |
|---|---|---|
| 600 mg sage/polyphenol combination | Active comparator | 600 mg of this sage/polyphenol combination will be consumed, via capsule, per day for 29 days. Receives: Dietary Supplement: Cognivia |
| Placebo | Placebo comparator | The same number of aesthetically similar capsules will be consumed per day for 29 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Secondary outcomes (4)
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.
Measured: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
Chronic 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start3 Sep 2018
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Wightman, Northumbria University
- Investigators
- Emma Wightman, Dr, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695003
- Sponsor's protocol ID
- 55C2
- Status last verified
- Mar 2020
- First submitted
- 20 Sep 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be shared among the named investigators and Nexira only.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study in Healthy Humans
- ClinicalTrials.gov ID
- NCT03695003
- Acronym / sponsor ID
- 55C2
- Conditions
- Cognitive Change, Mood Change
- Keywords
- Sage, Terpene, Polyphenol, Cognition, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.
| Arm | Type | Receives |
|---|---|---|
| 600 mg sage/polyphenol combination | Active comparator | Dietary Supplement: Cognivia600 mg of this sage/polyphenol combination will be consumed, via capsule, per day for 29 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe same number of aesthetically similar capsules will be consumed per day for 29 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CogniviaCognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira | Dietary supplement | 600 mg sage/polyphenol combination |
| PlaceboPlacebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules | Dietary supplement | Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Acute changes in blood pressure
Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
Chronic changes in blood pressure
Time frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Acute changes in heart rate
Time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation
Chronic changes in heart rate
Time frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No. The IPD will be shared among the named investigators and Nexira only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Wightman, Dr principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognivia in people with Cognitive Change and Mood Change, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in global cognitive task performance (time frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.