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

NCT05504668 | Completed

• 1 other identifier: 50BP1
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Mood Change; Microbial Colonization

Keywords

Turmeric; Cognition; Microbiome; Metabolome

Outcome Measures

Primary Outcomes (1)

• 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).

  90 days

Secondary Outcomes (7)

• Cognitive function (remote)

  90 days

• Mood (Anxiety)

  90 days

• Mood (General)

  90 days

• Prospective memory

  90 days

• Delayed recall

  90 days

Study Arms (2)

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).

Dietary Supplement: Turmeric Brainwave

Placebo

PLACEBO COMPARATOR

Magnesium Stearate

Dietary Supplement: Turmeric Brainwave

Interventions

Turmeric Brainwave DIETARY_SUPPLEMENT

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

Placebo; Turmeric Brainwave

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?'

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Pukka Herbs Limited: collaborator

Study Sites (1)

Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37885445 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma L Wightman, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: August 20, 2019
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)