RecruitingPhase 4ACTRN12618001841268

The effects of 3-months supplementation with Ubiquinol (CoQ10) on cognition and mood in healthy adults aged 60+.

The effects of 3-months supplementation with Ubiquinol (CoQ10) on cognition and mood in healthy adults aged over 60.


Sponsor

Kaneka Corporation

Enrollment

128 participants

Start Date

Mar 18, 2019

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Inclusion Criteria4

  • Non-smoking males and females aged 60 years and over
  • Willing and able to provide written informed consent
  • Understands and is willing and able to comply with all study procedures.
  • Fluent in written and spoken English

Exclusion Criteria42

  • Must have normal or corrected to normal vision
  • No recent history (past five years) of chronic severe illness (longer than six weeks)
  • Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
  • Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 3 hours).
  • Participant is willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
  • Participant is willing and able to provide 2 blood samples
  • Score of 19 or above on the Memory Complaint Questionnaire (MAC-Q)
  • Not currently participating in any other clinical trial
  • Has access to an internet device capable of online testing
  • 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).
  • Participants who report any of the following will be excluded from the trial;
  • Current smoker
  • 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.
  • Neurological conditions including epilepsy, Parkinson’s disease, Huntington’s Chorea and Myasthenia Gravis.
  • History of dementia, stroke and other neurological conditions.
  • Head trauma with loss of consciousness in the previous 6 months.
  • 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).
  • Cardiovascular disease
  • Current endocrine, gastrointestinal or bleeding disorders.
  • Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 90 mm Hg)
  • If female, pregnant or lactating.
  • Alcohol or drug abuse past or present
  • Other disorders affecting food metabolism, such as food allergies or intolerances
  • Recent history (past 5 years) of chronic/severe illness (longer than 6 weeks)
  • 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
  • A score below 19 on the MAC-Q
  • Vision that is not corrected to normal
  • Current regular alcohol use exceeding 14 standard drinks per week for women and 28 standard drinks per week for men
  • Current moderate or severe alcohol misuse disorder as defined in DSM5.
  • Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
  • Currently participating in or has participated in any other study involving an investigational product in the last 4 weeks.
  • Participant under administrative or legal supervision.
  • Allergy to the investigational product or formulation.
  • 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).

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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 partici

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.


Locations(1)

VIC, Australia

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ACTRN12618001841268


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