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

NCT ID: NCT05504668

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2022-02-02

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.

Conditions

Cognitive Change; Mood Change; Microbial Colonization

Study Design

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

Study Groups

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).

Group Type: EXPERIMENTAL

Turmeric Brainwave

Intervention Type: DIETARY_SUPPLEMENT

A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.

Placebo

Magnesium Stearate

Group Type: PLACEBO_COMPARATOR

Turmeric Brainwave

Intervention Type: DIETARY_SUPPLEMENT

A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.

Interventions

Turmeric Brainwave

A multiingredient herbal supplement with Turmeric as its most abundant single ingredient.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pukka Herbs Limited

UNKNOWN

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Emma Wightman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma L Wightman, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37885445 (View on PubMed)

Other Identifiers

50BP1

Identifier Type: -

Identifier Source: org_study_id