- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504668
The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults
August 22, 2022 updated by: Emma Wightman, Northumbria University
The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults Experiencing Subjective Memory Decline: A Randomized, Placebo Controlled, Parallel Groups Investigation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne And Wear
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Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
- Brain Performance and Nutrition Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Turmeric Brainwave
Turmeric Brainwaves (now Mind Focus) is a proprietorial herbal supplement from Pukka Herbs which contains (inc.
mg daily dose when 2 capsules combined); brahmi (320 mg), gotu kola leaf (144 mg), turmeric whole powder (116 mg), reishi full spectrum (116 mg), rosemary (116 mg), cardamom (88 mg), holy basil (86 mg), turmeric Wholistic™ extract (58 mg), green tea (58 mg) and seagreens (58 mg).
|
A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.
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Placebo Comparator: Placebo
Magnesium Stearate
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A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function (lab-based)
Time Frame: 90 days
|
This outcome will be assessed via changes on the cognitive task outcomes (measured via COMPASS).
COMPASS is a proprietorial software platform for delivering a range of cognitive tasks; assessing domains like memory and attention, with tasks scored for accuracy (% correct) and speed (msec).
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function (remote)
Time Frame: 90 days
|
This outcome will be assessed via changes on the cognitive task outcomes (measured via Cognimapp).
Cognimapp is a proprietorial software platform for delivering a range of cognitive tasks via mobile phone; assessing domains like memory and attention, with tasks scored for accuracy (% correct) and speed (msec).
|
90 days
|
Mood (Anxiety)
Time Frame: 90 days
|
This outcome will be assessed via changes on the Generalised Anxiety Disorder 7 (GAD 7) questionnaire.
This questionnaire comprises 7 items which are scored from 0 (not at all) to 3 (nearly every day) with a higher score indicating greater anxiety.
|
90 days
|
Mood (General)
Time Frame: 90 days
|
This outcome will be assessed via changes on Visual Analogue Scales (VAS).
This VAS is a 100 mm line with mood related adjectives anchoring each end of the line.
This is scored from mm distance along the line; with a higher score indicating greater feeling of that mood facet.
|
90 days
|
Prospective memory
Time Frame: 90 days
|
This facet of memory is assessed by the Prospective Remembering Video Procedure (PRVP) which is an 18-item list of locations and actions depicted within a 10-minute video.
Participants must encode these locations and actions and recall them when watching this video at a later date.
|
90 days
|
Delayed recall
Time Frame: 90 days
|
This is a real-world recall of 10 facts, created by the principal investigator for the purposes of this study, which participants encode at the start of the trial and must recall at the end.
|
90 days
|
Gut microbiota
Time Frame: 90 days
|
This will be assessed by any shifts in gut microbial species from a stool sample collected at the start of the trial compared to the stool sample taken at the end.
|
90 days
|
Urinary metabolome
Time Frame: 90 days
|
This will be assessed by any shifts in markers identified within the urinary metabolome from a urine sample collected at the start of the trial compared to the urine sample taken at the end.
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Emma L Wightman, PhD, Northumbria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2019
Primary Completion (Actual)
February 2, 2022
Study Completion (Actual)
February 2, 2022
Study Registration Dates
First Submitted
August 16, 2022
First Submitted That Met QC Criteria
August 16, 2022
First Posted (Actual)
August 17, 2022
Study Record Updates
Last Update Posted (Actual)
August 25, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50BP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
It is likely that we will make the data available upon request, via email, to the principal investigator but this still needs to be confirmed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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