search
Back to results

The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults

Primary Purpose

Cognitive Change, Mood Change, Microbial Colonization

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Turmeric Brainwave
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Change focused on measuring Turmeric, Cognition, Microbiome, Metabolome

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brain Performance and Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Turmeric Brainwave

Placebo

Arm Description

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).

Magnesium Stearate

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 16, 2022
Last Updated
August 22, 2022
Sponsor
Northumbria University
Collaborators
Pukka Herbs Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT05504668
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University
Collaborators
Pukka Herbs Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Mood Change, Microbial Colonization
Keywords
Turmeric, Cognition, Microbiome, Metabolome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind with a placebo control. The study funder organised the formulation of both the active and placebo capsules originally in 2019 so that they were aesthetically identical. Approximately half-way through the trial, the treatments expired due to Covid-19-induced delays and the remainder of the products required to complete the trial were reconstituted by staff at Northumbria University who had no further involvement in the trial. Capsules were again matched to be aesthetically identical between active and placebo but these treatments looked different to those in the first portion of the trial.
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turmeric Brainwave
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Magnesium Stearate
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric Brainwave
Intervention Description
A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.
Primary Outcome Measure Information:
Title
Cognitive function (lab-based)
Description
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).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cognitive function (remote)
Description
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).
Time Frame
90 days
Title
Mood (Anxiety)
Description
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.
Time Frame
90 days
Title
Mood (General)
Description
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.
Time Frame
90 days
Title
Prospective memory
Description
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.
Time Frame
90 days
Title
Delayed recall
Description
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.
Time Frame
90 days
Title
Gut microbiota
Description
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.
Time Frame
90 days
Title
Urinary metabolome
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma L Wightman, PhD
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Performance and Nutrition Research Centre
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults

We'll reach out to this number within 24 hrs