Cognitive Effects of Sage in Healthy Humans

NCT ID: NCT03695003

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-09-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

600 mg sage/polyphenol combination

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

Group Type: ACTIVE_COMPARATOR

Cognivia

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cognivia

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Emma Wightman

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Wightman, Dr

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

55C2

Identifier Type: -

Identifier Source: org_study_id