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| Name | Class |
|---|---|
| Pukka Herbs Limited | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Wholisticâ„¢ extract (58 mg), green tea (58 mg) and seagreens (58 mg). |
|
| Placebo | Placebo Comparator | Magnesium Stearate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turmeric Brainwave | Dietary Supplement | A multiingredient herbal supplement with Turmeric as its most abundant single ingredient. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma L Wightman, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Performance and Nutrition Research Centre | Newcastle upon Tyne | Tyne and Wear | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37885445 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 90 days |