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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
Date results information initially provided
3/11/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effects of coconut and fish oil on postprandial triglycerides (COmega Trial).
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Scientific title
The effects of coconut and fish oil on postprandial triglycerides (COmega Trial) in healthy individuals.
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Secondary ID [1]
298126
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N/A
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Universal Trial Number (UTN)
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Trial acronym
COmega Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postprandial blood lipids
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Condition category
Condition code
Metabolic and Endocrine
311153
311153
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0
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Normal metabolism and endocrine development and function
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Diet and Nutrition
311154
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314347
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Prevention
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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)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Blood triglyceride concentration
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
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Composite secondary outcome: blood cholesterol concentrations (total cholesterol, LDL-cholesterol, HDL-cholesterol, total cholesterol-to-HDL cholesterol ratio)
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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Postprandial blood glucose concentration
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Assessment method [2]
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Timepoint [2]
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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.
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Eligibility
Key inclusion criteria
• Healthy male or female
• Aged between 18 and 70 years
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
Placebo-controlled cross-over
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
30/04/2019
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Date of last participant enrolment
Anticipated
20/12/2019
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Actual
26/07/2019
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Date of last data collection
Anticipated
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Actual
26/07/2019
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Sample size
Target
15
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Newcastle
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Address [1]
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University Drive, Callaghan NSW 2308
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Newcastle
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Address
University Drive, Callaghan NSW 2308
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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N/A
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Address [1]
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N/A
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Country [1]
302577
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee (HREC) - University of Newcastle
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Ethics committee address [1]
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University of Newcastle Callaghan, NSW 2308 AUSTRALIA
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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19/10/2018
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Approval date [1]
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12/12/2018
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Ethics approval number [1]
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H-2018-0477
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Summary
Brief summary
Postprandial (post-meal consumption) blood triglyceride level has emerged as a clinically relevant risk factor for the development of cardiovascular disease. It is normal for postprandial triglycerides to rise after a fat-rich meal, however, elevated and excessive postprandial plasma triglyceride levels are associated with several cardio-metabolic events such as the formation of atherosclerosis.
Long chain omega 3 fatty acids (eicosapentanoic acid and docosahexaenoic acid) are established triglyceride lowering agents which are primarily obtained from marine sources or fish oil. Medium chain fatty acids (MCFA, 6-12 carbon atoms) derived from coconut oil have been shown to lower triglyceride levels and raise HDL-cholesterol compared to long-chain saturated fatty acids in preclinical studies.
The purpose of this trial is to investigate the combination of a single dose of dietary MCFA (coconut oil) and LCn-3PUFA (fish oil) on the post-meal rise in blood triglyceride levels in healthy individuals.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Manohar Garg
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Address
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Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 2 4921 5647
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jessica Ferguson
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Address
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Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 2 4921 5636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Manohar Garg
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Address
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Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308
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Country
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Australia
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Phone
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+61 2 4921 5647
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Publicly sharing individual data has not been approved in our ethics application.
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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
Source
Title
Year of Publication
DOI
Embase
Postprandial 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.
2021
https://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.
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