None listed
Conditions
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).
Interventions
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 the
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.
Sponsors
Kaneka Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
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).
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).
Outcome results
None listed