None listed
Conditions
Brief summary
This study aims to determine if an Omega-3 powder, rich in docosahexaenoic acid (DHA), can improve cognitive function and mood in healthy male participants aged between 40-60 years. A total of 30 participants will be recruited to take part in this trial. Previous clinical trials have demonstrated improvements in cognitive function and mood after supplementation with long-chain omega-3 fatty acids. This will be the first clinical trial to investigate the specific supplement at this dosage, however, the supplement is currently used as a food additive by a number of companies. The benefits of omega-3 supplements on health is well established, and has led to an increase in use, as well as the addition of omega-3 fatty acids in dietary supplements. Despite this, only a small number of controlled trials have directly investigated the acute (short-term) cognitive benefits associated with omega-3 supplementation. The current study therefore aims to investigate the acute effects of a DHA-rich omega-3 supplement on cognitive function. We will be measuring the effects of the omega-3 supplement compared to a placebo using assessments of mental fatigue, cognition, memory and mood.
Interventions
Driphorm HiDHA 360 powder:
The Investigational Product is a powder to be consumed orally (mixed with yoghurt). It is a spray dried powder containing concentrated Omega-3 marine oil, microencapsulated in a matrix of milk protein, sugars and antioxidants. Participants will be required to consume 12g of powder, mixed with a milk drink or yoghurt, in order to receive a 4g dose of DHA. They will consume this once during one of their 8-hour study visits within 10 minutes of being administered the pro
Driphorm HiDHA 360 powder: The Investigational Product is a powder to be consumed orally (mixed with yoghurt). It is a spray dried powder containing concentrated Omega-3 marine oil, microencapsulated in a matrix of milk protein, sugars and antioxidants. Participants will be required to consume 12g of powder, mixed with a milk drink or yoghurt, in order to receive a 4g dose of DHA. They will consume this once during one of their 8-hour study visits within 10 minutes of being administered the product (at the other visit they will receive placebo treatment. Testing visits are scheduled one week apart). Participants will consume the product directly under supervision of the research nurse to ensure compliance.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Outcome results
None listed