Cognitive Effects of Sage in Healthy Humans

NCT03695003 | Completed

• 1 other identifier: 55C2
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Mood Change

Keywords

Sage; Terpene; Polyphenol; Cognition; Mood

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (4)

• Acute changes in blood pressure

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

• Chronic changes in blood pressure

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

• Acute changes in heart rate

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

• Chronic changes in heart rate

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

Study Arms (2)

600 mg sage/polyphenol combination

ACTIVE COMPARATOR

600 mg of this sage/polyphenol combination will be consumed, via capsule, per day for 29 days.

Dietary Supplement: Cognivia

Placebo

PLACEBO COMPARATOR

The same number of aesthetically similar capsules will be consumed per day for 29 days.

Dietary Supplement: Placebo

Interventions

Cognivia DIETARY_SUPPLEMENT

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

600 mg sage/polyphenol combination

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Brain Performance and Nutrition Research Centre

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

Location

Study Officials

• Emma Wightman, Dr

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind. Randomized by a disinterested third party. Placebo and active capsules matched for aesthetics.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: The study will follow a randomised, double-blind, placebo-controlled, parallel groups design.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 3, 2018
• Study Start: September 3, 2018
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)