Effects of an Omega-3 powder rich in docosahexanoic acid (DHA) on cognitive and vascular function in healthy males

Exclusion Criteria34

• Must have normal, or corrected to normal vision.
• Participant is willing and able to provide four blood samples
• Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
• Participant is willing to abstain from foods containing high levels of Omega-3 (e.g. Oily fish, walnuts and avocado).
• Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
• Participant is willing to abstain from alcohol for 12 hours and vigorous physical activity for 12 hours prior to all study visits.
• History of dementia, stroke and other neurological conditions.
• 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
• Head trauma with loss of consciousness in the previous 6 months.
• Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea
• History of Anxiety, depression or other psychiatric disorders requiring treatment in the last 2 years.
• Current endocrine, gastrointestinal or bleeding disorders.
• Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure >90 mm Hg)
• Not willing to abstain from using vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, or other cognitive enhancing dietary or herbal supplements over the study period.
• Taking the following:
• i. Vitamin supplements including multivitamins, B vitamin complex, vitamin E
• ii. Herbal supplements including ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit.
• iii. Anti-coagulant drugs (warfarin, heparin, clopidogrel, ?aspirin, dipyrimidole, apixiban , rivaroxiban, dabigatran, tirofiban , ticagrelor);
• iv. anti-cholinergics or acetylcholinesterase inhibitors (bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), edrophonium (Enoln, Reversol, Tensilon), neostigmine (Prostigmin)) pyridostigmine (Mestinon)
• v. anti-depressant medications (table attached)
• vi. anti-anxiety medication such as diazepam (Valium), alprazolam (Xanax) or any other antianxiety medication including benzodiazepines
• vii. Hypnotics including benzodiazepines, zolpidem and zopiclone
• Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period.
• Have self-reported dyslexia.
• Current moderate or severe alcohol misuse disorder.
• Current substance misuse disorder (including misuse of prescription drugs)
• Current smoker.
• Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period.
• Excessive alcohol consumption (drinking on 5 or more days per week or consuming greater than 6 standard drinks on any one day) for 3 weeks prior to screening and during the intervention period.
• Allergy to any substance in the investigational product (i.e. seafood, bread and milk products)
• Currently consuming greater than 1 portion of oily fish per week
• Participation in another study with any investigational product within 30 days of screening and during the intervention period
• Participant under administrative or legal supervision