Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001160224
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
13/07/2018
Date last updated
20/06/2019
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an Omega-3 powder rich in docosahexanoic acid (DHA) on cognitive and vascular function in healthy males
Scientific title
Post prandial cognitive and vascular effects of DHA-rich Omega-3 powder in healthy middle-aged males
Secondary ID [1] 295362 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 308583 0
Vascular function 308584 0
Mood 308585 0
Condition category
Condition code
Mental Health 307537 307537 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 307645 307645 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301684 0
Treatment: Other
Comparator / control treatment
Placebo Powder:
The placebo treatment in the current study is a spray dried powder matched in appearance to the active treatment. The placebo powder contains 58% food grade sunflower oil, sodium caseinate, dextrose monohydrate, dried glucose syrup and sodium ascorbate. This powder will be mixed with the same milk drink or yoghurt as the active treatment and will be consumed once during one of the 8-hour study visits.
Control group
Placebo

Outcomes
Primary outcome [1] 306517 0
Change from baseline in reaction time on tasks in the Swinburne University Computerised Cognitive Ageing Battery (SUCCAB)
Timepoint [1] 306517 0
4 hours post-dose
Secondary outcome [1] 348745 0
Change from baseline in accuracy on tasks in the Swinburne University Computerised Cognitive Ageing Battery (SUCCAB)
Timepoint [1] 348745 0
4 hours post dose
Secondary outcome [2] 348746 0
Change from baseline in mood (assessed using the Depression, Anxiety and Stress Scale; DASS) following completion of the cognitive demand battery
Timepoint [2] 348746 0
4 hours post dose
Secondary outcome [3] 348747 0
Change from baseline in peripheral (brachial) blood pressure measured using the SphygmoCor XCEL system
Timepoint [3] 348747 0
4 hours post dose
Secondary outcome [4] 348748 0
Change from baseline in plasma fatty acids
Timepoint [4] 348748 0
4 hours post dose
Secondary outcome [5] 348749 0
Change from baseline in state anxiety assessed using the state-trait anxiety inventory (STAI)
Timepoint [5] 348749 0
4 hours post dose
Secondary outcome [6] 348750 0
Change from baseline in mood assessed using the Bond-Lader Visual Analogue Scales
Timepoint [6] 348750 0
4 hours post dose
Secondary outcome [7] 348751 0
Self-reported dietary intake assessed using the Food Frequency Questionnaire.
Timepoint [7] 348751 0
Single timepoint at start of study (prior to treatment)
Secondary outcome [8] 348752 0
Self-reported quality of life assessed using the General Health Questionnaire
Timepoint [8] 348752 0
Single timepoint at start of study (prior to treatment)
Secondary outcome [9] 348753 0
Change from baseline in reaction time on tasks in the Cognitive Demand Battery (CDB)
Timepoint [9] 348753 0
4 hours post dose
Secondary outcome [10] 348754 0
Change from baseline in accuracy on tasks in the CDB
Timepoint [10] 348754 0
4 hours post dose
Secondary outcome [11] 348755 0
Adverse events assessed using the Symptoms Checklist and participants' self-reports
Timepoint [11] 348755 0
Throughout study, participants will be questioned at the end of each testing session about their experience of adverse events
Secondary outcome [12] 349192 0
Change from baseline in central (aortic) blood pressure measured using the SphygmoCor XCEL system
Timepoint [12] 349192 0
4 hours post dose
Secondary outcome [13] 349193 0
Change from baseline in arterial stiffness calculated based on aortic blood pressure and wave reflection using the SphygmoCor XCEL system
Timepoint [13] 349193 0
4 hours post dose

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed from all personnel involved in participant recruitment, data collection, data entry and data analysis. The randomisation and labelling of study treatments was conducted by a disinterested third party. Study treatments are labelled only with the study title, name of the Principal Investigator, Participant ID code and Visit number, potential ingredients of the product and expiry date.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
For each outcome measure, data will be manually screened and (only) data deemed ‘invalid’ will be omitted from analyses. Data will be deemed invalid if a biological rationale sustains this assumption, e.g. non physiological values. These invalid data and the reason for exclusion will be reported in the final report. Demographic data will be presented with summary statistics (number of participants, mean, standard deviation, median and range). The number and percentage of subjects will be presented for categorical variables.
All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores will be calculated for each variable and displayed in histogram form. Scores greater than 3.29 which are disconnected from the data spread will be designated as outliers. Out of range values will be recoded as missing values.
Within-subject’s repeated measures ANOVAs will be used to analyse the primary and secondary parameters. Demographic data will be analysed using univariate analyses of variances (ANOVAs) in SPSS, applying standard statistical thresholds (p < 0.05), corrected for multiple comparisons where appropriate with two tailed significance level. Individual means will be obtained for each outcome measure and group means, collapsed across the two treatment arms, will be calculated to determine treatment effects. Relationships between mood and cognition variables will also be performed using Pearson’s correlation coefficient or the non-parametric equivalent, Spearman’s R.
As this study is a pilot study, a sample size determination has not been calculated. It is anticipated that data from 30 completed participants will not reach statistical power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/07/2018
Actual
27/07/2018
Date of last participant enrolment
Anticipated
28/06/2019
Actual
1/02/2019
Date of last data collection
Anticipated
19/07/2019
Actual
25/02/2019
Sample size
Target
15
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299957 0
Commercial sector/Industry
Name [1] 299957 0
Clover Corporation Limited
Country [1] 299957 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn
VIC 3122
Country
Australia
Secondary sponsor category [1] 299355 0
None
Name [1] 299355 0
Address [1] 299355 0
Country [1] 299355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300820 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 300820 0
Ethics committee country [1] 300820 0
Australia
Date submitted for ethics approval [1] 300820 0
27/04/2018
Approval date [1] 300820 0
22/06/2018
Ethics approval number [1] 300820 0
SHR project 2018/160

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84922 0
Prof Andrew Pipingas
Address 84922 0
Centre for Human Psychopharmacology (Mail H24)
Level 10, Advanced Technologies Centre
Faculty of Health, Arts and Design
Swinburne University of Technology
PO Box 218
Hawthorn,
VIC 3122
Country 84922 0
Australia
Phone 84922 0
+61 3 9214 5215
Fax 84922 0
Email 84922 0
[email protected]
Contact person for public queries
Name 84923 0
Naomi Perry
Address 84923 0
Centre for Human Psychopharmacology (Mail H24)
Level 10, Advanced Technologies Centre
Faculty of Health, Arts and Design
Swinburne University of Technology
PO Box 218
Hawthorn,
VIC 3122
Country 84923 0
Australia
Phone 84923 0
+61 3 9214 8930
Fax 84923 0
Email 84923 0
[email protected]
Contact person for scientific queries
Name 84924 0
Andrew Pipingas
Address 84924 0
Centre for Human Psychopharmacology (Mail H24)
Level 10, Advanced Technologies Centre
Faculty of Health, Arts and Design
Swinburne University of Technology
PO Box 218
Hawthorn,
VIC 3122
Country 84924 0
Australia
Phone 84924 0
+61 3 9214 5215
Fax 84924 0
Email 84924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated in peer reviewed publications and at academic conferences. For these purposes, data will be collated and analysed as group data. If requested by the publishing journal, de-identified raw data will be made available via an appropriate repository.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePost-Prandial Cognitive and Blood Pressure Effects of a DHA-Rich Omega-3 Powder in Middle-Aged Males: A Pilot Study.2023https://dx.doi.org/10.3390/nu15092198
N.B. These documents automatically identified may not have been verified by the study sponsor.