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Trial registered on ANZCTR


Registration number
ACTRN12619000921189
Ethics application status
Approved
Date submitted
12/06/2019
Date registered
2/07/2019
Date last updated
3/11/2020
Date data sharing statement initially provided
2/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of coconut and fish oil on postprandial triglycerides (COmega Trial).
Scientific title
The effects of coconut and fish oil on postprandial triglycerides (COmega Trial) in healthy individuals.
Secondary ID [1] 298126 0
N/A
Universal Trial Number (UTN)
Trial acronym
COmega Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postprandial blood lipids 312657 0
Condition category
Condition code
Metabolic and Endocrine 311153 311153 0 0
Normal metabolism and endocrine development and function
Diet and Nutrition 311154 311154 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will visit the Nutraceuticals clinical research facility after an overnight fast of at least 10 hours. Participants are provided with a 'Participant Information Statement', 'Consent Form' and 'Letter of Instructions to prepare for clinic appointments' (including other questionnaires) prior to their first clinic appointment. These documents outline how to fast. Participants are also sent a reminder email 1 week prior to each appointment as well as a text message the afternoon before each appointment to remind them to commence their fast and at what time in order to ensure adherence to the 10 hour fast period.
Following arrival, study participants will be randomly allocated to a single dose of these treatment arms (50g isocaloric dispersible powders containing active and/or placebo ingredients) delivered via a standardised meal on four visit days (once/week).

1. Olive oil + Tallow (PL): containing no fish oil (0g EPA & DHA) or coconut oil (0g MCFA)
2. Fish oil + Coconut oil (FO-CO): 18.65g coconut oil (15g MCFA), 6g fish oil (3g EPA & DHA)
3. Fish oil + Tallow oil (FO): 6g fish oil (3g EPA & DHA), 0g coconut oil (0g MCFA)
4. Coconut oil + Olive oil (CO): 18.65g coconut oil (15g MCFA)

Standardised meal includes: 160g tub of Greek Style Yoghurt, 1 slice of wholemeal bread (toasted), 14g berry jam, 1 medium cavendish banana and 200mL water. The isocaloric powders are mixed into the yoghurt for consumption.
Participants receive treatments with a washout period of one week.
The standardised meal enriched with the isocaloric powders will be provided to the participants by the study investigator and the participants are instructed to consume the meal within 10 minutes.
Intervention code [1] 314347 0
Prevention
Comparator / control treatment
Fish oil Placebo: Olive oil containing no fish oils (as isocaloric powder)
Coconut Oil Placebo: Tallow Oil containing no coconut oil (as isocaloric powder)
Control group
Placebo

Outcomes
Primary outcome [1] 319929 0
Blood triglyceride concentration
Timepoint [1] 319929 0
Week 1, week 2, week 3 and week 4.
At each visit, this outcome will be measured at timepoints: 0 hours (before ingestion of food) and 2 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours and 5 hours post meal consumption.
Secondary outcome [1] 369918 0
Composite secondary outcome: blood cholesterol concentrations (total cholesterol, LDL-cholesterol, HDL-cholesterol, total cholesterol-to-HDL cholesterol ratio)
Timepoint [1] 369918 0
Week 1, Week 2, Week 3 and Week 4. At each visit, this outcome will be measured at timepoints: 0 hours (before ingestion of food) and 2 hours, 3 hours, 3.5 hours, 4 hours, 4.5 hours and 5 hours post meal consumption.
Secondary outcome [2] 369919 0
Postprandial blood glucose concentration
Timepoint [2] 369919 0
Week 1, week 2, week 3 and week 4. At each visit, this outcome will be measured at timepoints: 0 hours (before ingestion of food) and 2 hours post meal consumption.

Eligibility
Key inclusion criteria
• Healthy male or female
• Aged between 18 and 70 years
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• BMI > 40 kg/m2
• Pregnant or breast feeding
• Taking hypolipidaemic medications (e.g. Lipitor, Crestor, Zocor)
• Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin)
• Dieting or have any eating disorders
• Strong allergies/intolerances/sensitivities to any of the food products or ingredients used in the study
• History of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD; or pulmonary disease
• A chronic inflammatory disease (e.g. cancer)
• Diabetes Mellitus (Type 1 and Type 2)
• Liver or kidney related diseases
• Fasting triglyceride levels higher than 3.0 mmol/L
• History of gastrointestinal disorder and gall bladder disease
• Smoke
• History of severe neurological diseases or seizures
• Pace maker implants
• Vegetarian or vegan
• Exercise more than 30minutes/d on four or more days of the week

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be conducted by the chief investigator who assigned alphabetical codes onto the study powder sachets by labelling them with a alphabetical code. The lead investigators and co-investigators were blinded to the allocation assignment, and the chief investigator stored the allocation sequence in a locked filing cabinet at the trial facility.

Volunteers were assessed for eligibility by the lead investigator, who then allocated participants to treatment groups using a computer generated randomization code. As mentioned above, the randomisation code had been assigned treatment interventions by the chief investigator in order to ensure all other study investigators were blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatments will be based on the computer generated block randomization method to ensure well-balanced groups.
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
Placebo-controlled cross-over
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Determination:
Based on the anticipated 30% difference in primary outcome, iAUC for postprandial TG levels, at the 0.05 level of significance, 80% power, standard deviation of 114 in iAUC (1) and 10% dropout rate, n=15 subjects will be required for the cross over design.
Data Analysis:
The effect of test foods on blood lipids, and other biomarkers will be determined by using repeated measure ANOVA with post hoc comparisons (Tukey’s honestly significant difference). Baseline data will be used as covariates and changes from the baselines will be determined using paired t-test. Data will be presented as mean ± SEM or median and IQR as appropriate, a p-value <0.05 will be considered significant.

Reference:
1. Berry SE, Tydeman EA, Lewis HB, Phalora R, Rosborough J, Picout DR, et al. Manipulation of lipid bioaccessibility of almond seeds influences postprandial lipemia in healthy human subjects. Am J Clin Nutr. 2008;88(4):922-9.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/04/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
26/07/2019
Date of last data collection
Anticipated
Actual
26/07/2019
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302657 0
University
Name [1] 302657 0
University of Newcastle
Country [1] 302657 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 302577 0
None
Name [1] 302577 0
N/A
Address [1] 302577 0
N/A
Country [1] 302577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303279 0
Human Research Ethics Committee (HREC) - University of Newcastle
Ethics committee address [1] 303279 0
Ethics committee country [1] 303279 0
Australia
Date submitted for ethics approval [1] 303279 0
19/10/2018
Approval date [1] 303279 0
12/12/2018
Ethics approval number [1] 303279 0
H-2018-0477

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

Contacts
Principal investigator
Name 93114 0
Prof Manohar Garg
Address 93114 0
Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
Country 93114 0
Australia
Phone 93114 0
+61 2 4921 5647
Fax 93114 0
Email 93114 0
[email protected]
Contact person for public queries
Name 93115 0
Jessica Ferguson
Address 93115 0
Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
Country 93115 0
Australia
Phone 93115 0
+61 2 4921 5636
Fax 93115 0
Email 93115 0
[email protected]
Contact person for scientific queries
Name 93116 0
Manohar Garg
Address 93116 0
Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
Country 93116 0
Australia
Phone 93116 0
+61 2 4921 5647
Fax 93116 0
Email 93116 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
Publicly sharing individual data has not been approved in our ethics application.


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
EmbasePostprandial lipaemia following consumption of a meal enriched with medium chain saturated and/or long chain omega-3 polyunsaturated fatty acids. A randomised cross-over study.2021https://dx.doi.org/10.1016/j.clnu.2020.06.027
N.B. These documents automatically identified may not have been verified by the study sponsor.