ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Diet and Nutrition

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]

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]

Blood triglyceride concentration

Timepoint [1]

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]

Composite secondary outcome: blood cholesterol concentrations (total cholesterol, LDL-cholesterol, HDL-cholesterol, total cholesterol-to-HDL cholesterol ratio)

Timepoint [1]

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]

Postprandial blood glucose concentration

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

University Drive, Callaghan NSW 2308

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive, Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (HREC) - University of Newcastle

Ethics committee address [1]

University of Newcastle Callaghan, NSW 2308 AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/10/2018

Approval date [1]

12/12/2018

Ethics approval number [1]

H-2018-0477

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Manohar Garg

Address

Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

manohar.garg@newcastle.edu.au

Contact person for public queries

Name

Jessica Ferguson

Address

Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5636

Fax

jessica.ferguson@newcastle.edu.au

Contact person for scientific queries

Name

Manohar Garg

Address

Nutraceuticals Research Program 305C Medical Science Building University Drive University of Newcastle Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

manohar.garg@newcastle.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

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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Documents added manually

Documents added automatically