Clinical trial NCT05504668: The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults
Official title: The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults Experiencing Subjective Memory Decline: A Randomized, Placebo Controlled, Parallel Groups Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Mood Change
Microbial Colonization
Keywords: Turmeric
Cognition
Microbiome
Metabolome
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Pukka Herbs Limited
First posted: 2022-08-17
Enrollment: 174
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigated the effects of a proprietorial herbal supplement, Turmeric Brainwave (now Mind focus), on cognition, mood and the microbiome in older adults experiencing subjective memory decline, following 90 days supplementation.

Detailed description: The primary aim of this randomised, double blind, placebo-controlled, parallel groups study was to assess the effects of a daily dose of Turmeric Brainwaves, versus placebo, both acutely and following 90 days consumption. Effects were to be assessed in 55-75 year old males and females who reported that their memory now was worse than when in their 20's. Effects were assessed via cognitive (including COMPASS and Cognimapp as well as 2 real-world long-term memory tasks (location-action (AKA Prospective Remembering Video Procedure (PRVP)) and recall of facts)) and mood (using visual analogue scales) outcomes and, additionally, stool and urine samples collected at the beginning and the end of the trial period assessed the microfloral community of the gut and urinary metabolome.

Eligibility criteria: Inclusion Criteria:

* 55-75 years at time of enrolment
* Answers yes to the question 'would you say that your memory now is worse now than it used to be in your 20's?'

Exclusion Criteria:

* Pre-existing medical condition/illnesses which would impact taking part in the study The explicit exceptions to this were controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. Other, unforeseen, exceptions were considered on a case-by-case basis; i.e. participants may have progressed to screening if they had a condition/illness which would not interact with the active treatments or impede performance.
* Currently taking prescription medications The explicit exceptions to this were contraceptive and hormone replacement treatments for female participants where symptoms were stable and treatment would 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 have been other instances of permitted medication use where no interaction with the active treatments was anticipated.
* High blood pressure (BP; systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
* Pregnant, seeking to become pregnant or lactating
* Learning and/or behavioural difficulties such as dyslexia or Attention Deficit Hyperactivity Disorder (ADHD)
* Visual impairments not corrected with glasses or contact lenses (including colour-blindness)
* Smoking (including vaping)
* Excessive caffeine intake (\>500 mg per day)
* Clinically diagnosed food intolerances/sensitivities
* Antibiotic, prebiotic or probiotic (including drinks; e.g. Yakult or Actimel) use within the past 8 weeks
* Health conditions preventing fulfilment of the study requirements (this included non-diagnosed conditions for which no medication was taken)
* Inability to complete all of the study assessments
* Currently participating in other clinical or nutrition intervention studies, or had in the past 4 weeks (8 weeks if a probiotic study)
* Diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
* Diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
* Suffering 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

Primary outcomes:
measure: Cognitive function (lab-based)
timeFrame: 90 days
Secondary outcomes:
measure: Cognitive function (remote)
timeFrame: 90 days
measure: Mood (Anxiety)
timeFrame: 90 days
measure: Mood (General)
timeFrame: 90 days
measure: Prospective memory
timeFrame: 90 days
measure: Delayed recall
timeFrame: 90 days
measure: Gut microbiota
timeFrame: 90 days
measure: Urinary metabolome
timeFrame: 90 days
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Brain Performance and Nutrition Research Centre
state: Tyne And Wear
Study officials:
affiliation: Northumbria University
name: Emma L Wightman, PhD
role: PRINCIPAL_INVESTIGATOR
References: