A randomised study with placebo control to assess the effects of Ergothioneine (ERG-001) on Cognition, Mood and Sleep in both adult men and woman aged between 55 and 79 years of age.
A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine (ERG-001) on Cognition, Mood, and Sleep in Adult Men and Women at 4 and 16 weeks.
Blue California Ingredients
150 participants
Mar 16, 2022
Interventional
Conditions
Summary
This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of two screening visits, one baseline visit (day 0), and two treatment visits (day +28, and +112;). At the baseline visit, subjects will be randomly assigned to one of three treatment groups. The primary aim of this proposed study is to determine the effects of daily Ergothioneine consumption in older adults (59-79 years of age) on a range of outcomes. Older adults who self-report memory complaints (i.e. subjectively experience impairments in their cognitive function) will be recruited from the general population. Participants will be assigned to receive either 25 mg of Ergothioneine per day, 10 mg of Ergothioneine per day, or a placebo control. The impact of the intervention will be assessed at 0 days, 28 days and 112 days of taking Ergothioneine daily for 112 days. Participants attend all study visits in a fasted state where they will consume a low-GI breakfast after providing blood samples, and prior to their cognitive assessment; the same breakfast meal is then adhered to over subsequent visits. At the screening visits, subjects will provide informed consent and undergo screening procedures to determine eligibility. Study procedures will be completed including vital signs and resting blood pressure, heart rate, respiration rate and temperature check. The height, weight, and BMI will also be assessed, as will CNS-VS test battery, the Prospective-Retrospective Memory Questionnaire, the Leeds Sleep Evaluation Questionnaire (LSEQ), and the Profile of Mood States (POMS) Questionnaire will also be administered. A non-fasting venous blood draw will be completed to collect samples for a chemistry profile, hematology profile, hs-CRP, ergothioneine, telomere length, and inflammatory markers. Concomitant medications/supplements, inclusion/exclusion criteria and any adverse events will be reviewed at each visit .
Eligibility
Inclusion Criteria6
- Males and females
- Aged >=55 & <=79 years of age at Informed Consent
- Scores >=25 on the subjective memory complaints questionnaire (MAC-Q)
- BMI >=18.5 and <=35 at time of clinic screening
- Willing and able to provide Informed Consent
- Able to access own email address
Exclusion Criteria21
- Currently depressed (indicated by scores equal or greater to a score of 6 on GDS 15 questionnaire ).
- Score of less or equal to 22 on the MoCA.
- Self-reported Colour Blindness.
- Aversion and/or intolerance/allergy to any of the following: Mushrooms, Microcrystalline cellulose, vegetarian capsules (hypromellose, purified water, titanium dioxide, carrageenan, pectin), magnesium stearate, or silicon dioxide.
- Any condition or event, as confirmed by the trained Clinical Team Member, where cognitive impairment may occur, including but not limited to: head injury that required hospitalisation, brain surgery, transient ischemic attacks, stroke, coronary artery bypass surgery, other heart surgery, degenerative neurological disease, which in the opinion of the Investigator may affect the participant’s ability to participate in the study or the study results.
- Previous diagnosis of Type 1 Diabetes.
- HbA1c greater or equal to 6.5% for non-diabetics (equal to 48mmol/mol) or greater or equal to 7% (less or equal to 53mmol/mol) if diagnosed with Type 2 Diabetes and medically managed for at least 6 months, assessed at screening.
- Untreated hypertension (Blood pressure equal to 155 mmHg and diastolic equal to 100 mmHg, obtained over three readings at the screening visit (unless applicant obtains a letter from medical professional indicating fit for inclusion)).
- Current smoker (or history of smoking including within last 6 months).
- History of Intellectual Disability or other developmental disorder (e.g., language disorder, ADHD, Autism).
- Any mental health condition that is being actively treated either pharmacologically or by a licensed mental health professional .
- Has undergone Chemotherapy or Radiotherapy treatment within preceding two years of screening.
- Any of the following sleep disorders: Insomnia, Restless Legs Syndrome, Narcolepsy, Idiopathic Hypersomnia, Circadian Rhythm Disorders, Sleep Apnoea (unless actively treated by CPAP for at least the preceding 6-months).
- Participation in a study utilising the same cognitive assessment measures within the previous 90 days of screening.
- Self-reported regular use of sedatives (e.g., tranquillizers, Benzodiazepines,
- antihistamines etc) to aid sleep defined as 3 or more nights per week over the four weeks preceding screening.
- Self-reported alcohol intake exceeding 1 standard drink per day on average over the four weeks preceding screening in accordance with the Australian Government Guidelines.
- Current or recent participation (within the last 60 days of screening) in any other clinical trial involving the administration of an active intervention for any purpose.
- Consumption of more than one serve (approx. half a cup raw) of mushrooms per week on average over the 4 weeks preceding baseline assessment.
- Consumption of greater than 400 mg/d intake of Caffeine per day averaged over the 4 weeks preceding screening.
- Blood haematology and biochemistry test results outwith the normal reference range at screening, in the opinion of the treating doctor.
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Interventions
Ergothionenine is the name of the investigational product. Participants will be assigned to receive one of three arms: ARM 1: 25mg Ergothioneine, one oral capsule, per day for 112 days ARM 2: 10mg of Ergothioneine, one oral capsule, per day for 112 days ARM 3: 0mg placebo control, one oral capsule, per day for 112 days All participants will be required to take 1 capsule, orally at the same time every day for 112 days. Bottles will be returned by the patient to the site for accountability in every instance. The patient will also be queried about their adherence to the regime in addition to completing a daily intake log via a compliance monitoring application. The impact of the intervention will be assessed at +16 weeks (+112 days), with some interim measures completed at +4 weeks (+28 days).
Locations(1)
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ACTRN12621001607864