Cognitive ChangeNCT05504668
The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults
A study testing Turmeric Brainwave in people with Cognitive Change and Mood Change, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood Change, Microbial Colonization
- What is being tested?
- Turmeric Brainwave
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2019to 2 Feb 2022
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?'
Who cannot join
- 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)
Show all 21Show fewer
- 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
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 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.
Read the 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.
- Conditions
- Cognitive Change, Mood Change, Microbial Colonization
- Being tested
- Turmeric Brainwave
- Keywords
- Turmeric, Cognition, Microbiome, Metabolome
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turmeric BrainwaveDietary supplement
A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Turmeric Brainwave | Experimental | 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). Receives: Dietary Supplement: Turmeric Brainwave |
| Placebo | Placebo comparator | Magnesium Stearate Receives: Dietary Supplement: Turmeric Brainwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function (lab-based)
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).
Measured: 90 days
Secondary outcomes (7)
Cognitive function (remote)
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).
Measured: 90 days
Mood (Anxiety)
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.
Measured: 90 days
Mood (General)
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.
Measured: 90 days
Prospective memory
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.
Measured: 90 days
Delayed recall
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.
Measured: 90 days
Gut microbiota
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.
Measured: 90 days
Urinary metabolome
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start20 Aug 2019
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Pukka Herbs Limited
- Responsible party
- Principal investigator, Emma Wightman, Northumbria University
- Investigators
- Emma L Wightman, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504668
- Sponsor's protocol ID
- 50BP1
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Wightman E, Khan J, Smith E, Rolfe V, Smith D, Young G, Cheung W, Kennedy D. Chronic supplementation of a multi-ingredient herbal supplement increases speed of cognitive task performance alongside changes in the urinary metabolism of dopamine and the gut microbiome in cognitively intact older adults experiencing subjective memory decline: a randomized, placebo controlled, parallel groups investigation. Front Nutr. 2023 Oct 10;10:1257516. doi: 10.3389/fnut.2023.1257516. eCollection 2023.
PubMed 37885445
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults Experiencing Subjective Memory Decline: A Randomized, Placebo Controlled, Parallel Groups Investigation
- ClinicalTrials.gov ID
- NCT05504668
- Acronym / sponsor ID
- 50BP1
- Conditions
- Cognitive Change, Mood Change, Microbial Colonization
- Keywords
- Turmeric, Cognition, Microbiome, Metabolome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Pukka Herbs Limited
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 17 Aug 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turmeric Brainwave | Experimental | Dietary Supplement: Turmeric BrainwaveTurmeric 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). |
| Placebo | Placebo comparator | Dietary Supplement: Turmeric BrainwaveMagnesium Stearate |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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?'
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| Turmeric BrainwaveA multiingredient herbal supplement with Turmeric as its most abundant single ingredient. | Dietary supplement | Placebo, Turmeric Brainwave |
Primary outcome
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).
7 secondary outcomes
Cognitive function (remote)
Time frame: 90 days
Mood (Anxiety)
Time frame: 90 days
Mood (General)
Time frame: 90 days
Prospective memory
Time frame: 90 days
Delayed recall
Time frame: 90 days
Gut microbiota
Time frame: 90 days
Urinary metabolome
Time frame: 90 days
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 25 Aug 2022.
- Derived from this study: PubMed 37885445Wightman E, Khan J, Smith E, Rolfe V, Smith D, Young G, Cheung W, Kennedy D. Chronic supplementation of a multi-ingredient herbal supplement increases speed of cognitive task performance alongside changes in the urinary metabolism of dopamine and the gut microbiome in cognitively intact older adults experiencing subjective memory decline: a randomized, placebo controlled, parallel groups investigation. Front Nutr. 2023 Oct 10;10:1257516. doi: 10.3389/fnut.2023.1257516. eCollection 2023.
- Individual participant dataSharing planned: No. 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.
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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 L Wightman, PhD 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 Turmeric Brainwave 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 2 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 25 Aug 2022. 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?
Cognitive function (lab-based) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504668, which also lists 1 linked publication.
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 25 Aug 2022.