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

Phase 1

Completed

• Conditions: Cognitive function; Vascular function; Mood; Mental Health - Studies of normal psychology, cognitive function and behaviour; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12618001160224
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-13
• Study Completion: 2019-02-25
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

1.Male, aged 40-60 years, inclusive.
2.Willing and able to provide written informed consent.
3.Ability of the participant (in the Principal Investigator’s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
4.Agree to comply with the protocol and study restrictions.
5.Available for all study visits
6.Fluent in written and spoken English.
7.In good general health as indicated by the absence of exclusion criteria.
8.Must have normal, or corrected to normal vision.
9.Participant is willing and able to provide four blood samples
10.Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
11.Participant is willing to abstain from foods containing high levels of Omega-3 (e.g. Oily fish, walnuts and avocado).
12.Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
13.Participant is willing to abstain from alcohol for 12 hours and vigorous physical activity for 12 hours prior to all study visits.

Exclusion Criteria

1.History of dementia, stroke and other neurological conditions.
2.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).
3.Cardiovascular disease
4.Head trauma with loss of consciousness in the previous 6 months.
5.Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea
6.History of Anxiety, depression or other psychiatric disorders requiring treatment in the last 2 years.
7.Current endocrine, gastrointestinal or bleeding disorders.
8.Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure >90 mm Hg)
9.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.
10.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
11.Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period.
12.Have self-reported dyslexia.
13.Current moderate or severe alcohol misuse disorder.
14.Current substance misuse disorder (including misuse of prescription drugs)
15.Current smoker.
16.Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period.
17.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.
18.Allergy to any substance in the investigational product (i.e. seafood, bread and milk products)
19.Currently consuming greater than 1 portion of oily fish per week
20.Participation in another study with any investigational product within 30 days of screening and during the intervention period
21.Participant under administrative or legal supervision

Study & Design

• Study Type: Interventional
• Study Design: Not specified