Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001841268
Ethics application status
Approved
Date submitted
11/10/2018
Date registered
12/11/2018
Date last updated
26/02/2020
Date data sharing statement initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of 3-months supplementation with Ubiquinol (CoQ10) on cognition and mood in healthy adults aged 60+.
Scientific title
The effects of 3-months supplementation with Ubiquinol (CoQ10) on cognition and mood in healthy adults aged over 60.
Secondary ID [1] 296295 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 309967 0
Mood 309968 0
Cardiovascular Function 309969 0
Condition category
Condition code
Mental Health 308741 308741 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 308742 308742 0 0
Normal development and function of the cardiovascular system
Alternative and Complementary Medicine 308743 308743 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ubiquinol CoQ10

Participants will be required to take one capsule orally, twice daily with food (one in the morning and one in the evening). Each capsule contains 100mg Ubiquinol, therefore participants will consume 200mg each day for 3 months. Participants will be provided with a 3-month supply of the study product at their baseline visit and will then take the capsules twice daily in their own home.

Participants will be provided with a diary/log that they will be instructed to tick when they have taken their treatment each day. In addition, they will be required to return any left over treatment at their final visit so that compliance can be calculated based on capsule count.
Intervention code [1] 312625 0
Treatment: Drugs
Comparator / control treatment
Placebo

Soft gelatin capsule containing the same ingredients as the active treatment, minus the Ubiquinol. Participants will be required to consume two capsules daily, with food. The capsules are identical in taste and appearance to the active capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 307739 0
Memory composite score (from CogTrack cognitive testing battery memory tasks)
Timepoint [1] 307739 0
90 days post first dose
Secondary outcome [1] 352754 0
Non-memory cognitive function (measured using CogTrack computerised cognitive battery, Rey's Auditory Verbal Learning Test, Neuropsychological Battery)
Timepoint [1] 352754 0
90 days post first dose
Secondary outcome [2] 352755 0
Mood (measured using the profile of mood states questionnaire)
Timepoint [2] 352755 0
90 days post first dose
Secondary outcome [3] 352756 0
Reaction time (measured using the inspection time task)
Timepoint [3] 352756 0
90 days post first dose
Secondary outcome [4] 352758 0
Cardiovascular function (measured using SphygmoCor and BPPro wristwatch)
Timepoint [4] 352758 0
90 days post first dose
Secondary outcome [5] 352759 0
Oxidative stress (measured as F2 isoprostanes in blood)
Timepoint [5] 352759 0
90 days post first dose
Secondary outcome [6] 352760 0
Inflammation (measured as HsCRP in blood)
Timepoint [6] 352760 0
90 days post first dose
Secondary outcome [7] 352761 0
Liver function (measured as liver enzymes in blood)
Timepoint [7] 352761 0
90 days post first dose
Secondary outcome [8] 352762 0
Subjective memory (measured using the prospective and retrospective memory questionnaire)
Timepoint [8] 352762 0
90 days post first dose
Secondary outcome [9] 353066 0
Blood levels of CoQ10
Timepoint [9] 353066 0
90 days post first dose
Secondary outcome [10] 353067 0
Blood levels of glutathione peroxidase
Timepoint [10] 353067 0
90 days post first dose
Secondary outcome [11] 354920 0
Change in distance walked on 6-minute walk test between baseline and 90-day follow-up
Timepoint [11] 354920 0
90 days post first dose
Secondary outcome [12] 354921 0
Difference in ratings of dyspnea before and after the 6-minute walk test (measured using the Borg scale)
Timepoint [12] 354921 0
90 days post first dose
Secondary outcome [13] 354922 0
Difference in ratings of fatigue before and after the 6-minute walk test (measured using the Borg scale)
Timepoint [13] 354922 0
90 days post first dose

Eligibility
Key inclusion criteria
Participants who meet the following inclusion criteria will be included in the trial;
1. Non-smoking males and females aged 60 years and over
2. Willing and able to provide written informed consent
3. Understands and is willing and able to comply with all study procedures.
4. Fluent in written and spoken English
5. Participants must be in general good health defined for the purposes of this study by the absence of the exclusion criteria
6. Must have normal or corrected to normal vision
7. No recent history (past five years) of chronic severe illness (longer than six weeks)
8. Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
9. Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 3 hours).
10. Participant is willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
11. Participant is willing and able to provide 2 blood samples
12. Score of 19 or above on the Memory Complaint Questionnaire (MAC-Q)
13. Not currently participating in any other clinical trial
14. Has access to an internet device capable of online testing
15. For inclusion in the 6MWT test only – In the opinion of the Research Nurse, at low risk of an adverse event occurring during physical activity/exercise (based on responses to the Adult Pre-exercise Screening Tool).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who report any of the following will be excluded from the trial;
1. Current smoker
2. Psychiatric disorder requiring treatment in the previous two years. Treatment includes prescription of antidepressant, antipsychotic or other long term medication and/or referral for long term psychotherapy. It does not include brief interventions for normal life events such as exam anxiety or bereavement.
3. Neurological conditions including epilepsy, Parkinson’s disease, Huntington’s Chorea and Myasthenia Gravis.
4. History of dementia, stroke and other neurological conditions.
5. Head trauma with loss of consciousness in the previous 6 months.
6. History of Type I diabetes (insulin dependent) or Type II diabetes on treatment. (Type II diabetes and prediabetes treated with diet alone is not an exclusion).
7. Cardiovascular disease
8. Current endocrine, gastrointestinal or bleeding disorders.
9. Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 90 mm Hg)
10. If female, pregnant or lactating.
11. Alcohol or drug abuse past or present
12. Other disorders affecting food metabolism, such as food allergies or intolerances
13. Recent history (past 5 years) of chronic/severe illness (longer than 6 weeks)
14. Taking the following (and not willing to abstain for the duration of the trial):
i. Coenzyme Q10 , ezetimibe therapy, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, antioxidants or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit
ii. Anti-coagulant drugs (warfarin, heparin, clopidogrel, aspirin, dipyrimidole, apixiban, rivaroxiban, dabigatran, tirofiban, ticagrelor);
iii. anti-cholinergics or acetylcholinesterase inhibitors (bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), edrophonium (Enoln, Reversol, Tensilon), neostigmine (Prostigmin) pyridostigmine (Mestinon)
iv. anti-depressant medications
v. anti-anxiety medication such as diazepam (Valium), alprazolam (Xanax) or any other antianxiety medication including benzodiazepines
vi. Hypnotics including benzodiazepines, zolpidem and zopiclone
vii. Illicit drugs
viii. Antipsychotic drugs
15. A score below 19 on the MAC-Q
16. Vision that is not corrected to normal
17. Current regular alcohol use exceeding 14 standard drinks per week for women and 28 standard drinks per week for men
18. Current moderate or severe alcohol misuse disorder as defined in DSM5.
19. Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
20. Currently participating in or has participated in any other study involving an investigational product in the last 4 weeks.
21. Participant under administrative or legal supervision.
22. Allergy to the investigational product or formulation.
23. For exclusion from the 6MWT test only – In the opinion of the Research Nurse, at high risk of an adverse event occurring during physical activity/exercise (based on responses to the Adult Pre-exercise Screening Tool).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation codes were generated using specialist randomisation computer software by a disinterested third party. An electronic copy of the codes is kept in a password-protected file not accessible by the study team. Hard copies are also kept in a sealed envelope in a locked filing cabinet not accessible by the study team.
Randomisation codes were allocated based on participant number. Participant numbers will be allocated as participants enter the trial, in the order that they entered the trial (i.e. the first participant to sign consent will be allocated participant number 001 etc.). Treatment allocation will be based on participant number, such that the randomisation number is always the same as the participant number. Participant 001 will receive treatments in the order allocated to randomisation number 001 etc. This will reduce the likelihood of errors being made in treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised code list was created using the generator at https://www.sealedenvelope.com/simple-randomiser/v1/lists. The two possible treatment conditions (Active and Placebo) were arbitrarily named Treatment A, Treatment B. This was then entered into the Generator with the total number of subjects being 128 and random block sizes of 4, 6 and 8.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/01/2019
Actual
18/03/2019
Date of last participant enrolment
Anticipated
13/07/2020
Actual
Date of last data collection
Anticipated
16/10/2020
Actual
Sample size
Target
128
Accrual to date
110
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300887 0
Commercial sector/Industry
Name [1] 300887 0
Kaneka Corporation
Country [1] 300887 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Kaneka Corporation
Address
3-2-4 Nakanoshima
Kita-Ku
Osaka 530-8288
Country
Japan
Secondary sponsor category [1] 300451 0
University
Name [1] 300451 0
Swinburne University of Technology
Address [1] 300451 0
John Street
Hawthorn
VIC 3122
Country [1] 300451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301660 0
Swinburne University Human Research Ethics Committee [EC00240]
Ethics committee address [1] 301660 0
John Street
Hawthorn
VIC 3122
Ethics committee country [1] 301660 0
Australia
Date submitted for ethics approval [1] 301660 0
30/08/2018
Approval date [1] 301660 0
17/12/2018
Ethics approval number [1] 301660 0
SHR project 2018/323

Summary
Brief summary
We propose to study the effects of 3 month supplementation of CoQ10 on cognition versus placebo using a randomized controlled trial methodology. Our focus will be on older participants as this may be a sensitive age for cognitive improvement given that normal increasing age is associated with cognitive decline-particularly memory, the levels of CoQ10 decreases with age, there is increased deterioration in the cardiovascular system with age and finally there is increased oxidative stress with age and less anti-oxidant protection with age. All of these indicators suggest that supplementation with CoQ10 could improve cognitive function in the elderly. Apart from our sensitive cognitive battery we will also measure changes in blood levels of CoQ10 and oxidative stress (F2 Isoprostanes and glutathione peroxidase) as well as markers of cardiovascular function (Blood pressure, arterial stiffness and blood flow).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87698 0
Prof Con Stough
Address 87698 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 87698 0
Australia
Phone 87698 0
+61 3 9214 8167
Fax 87698 0
Email 87698 0
[email protected]
Contact person for public queries
Name 87699 0
Dr Naomi Perry
Address 87699 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 87699 0
Australia
Phone 87699 0
+61 3 9214 8930
Fax 87699 0
Email 87699 0
[email protected]
Contact person for scientific queries
Name 87700 0
Prof Con Stough
Address 87700 0
Swinburne University of Technology
Centre for Human Psychopharmacology
ATC Building, Mail H24
John Street,
Hawthorn
Victoria
3122
Country 87700 0
Australia
Phone 87700 0
+61
Fax 87700 0
Email 87700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results from this trial will be presented at conferences and published in peer reviewed journals and in student theses. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.