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Trial registered on ANZCTR

Registration number

ACTRN12613000875707

Ethics application status

Approved

Date submitted

2/08/2013

Date registered

6/08/2013

Date last updated

7/08/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

Consumption of fish oil and a Mediterranean influenced antioxidant diet on telomere length in older Australians:
Adherence and feasibility from a pilot study

Scientific title

Adherence and feasibility following consumption of fish oil or a Mediterranean influenced antioxidant diet: a pilot study

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

At risk of cardiovascular disease

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

12 week intervention assessing a Mediterranean influenced antioxidant diet (MAx) in which participants were provided 15g walnuts, 7.5g hazelnuts, and 7.5g almonds per day, pre-packed into weekly allowances, and 20ml virgin olive oil per day; commercially available from a large supermarket chain in Australia.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

12 week intervention assessing a fish oil capsule supplemented diet (provided nine capsules per day), with either higher dose n-3 PUFA (~1.5g EPA and 1g DHA), OR a lower dose n-3 PUFA (containing 10% of the active dose; control).

Control group

Active

Outcomes

Primary outcome [1]

Adherence to fish oil capsules through fish oil diaries that recorded daily capsule consumption, adverse reactions, and reasons for missed doses.

Timepoint [1]

Baseline and 12 weeks

Primary outcome [2]

Adherence to the MAx diet through a validated Mediterranean diet score, self-reported daily diaries stating weekly nut consumption, and self-reported remaining olive oil.

Timepoint [2]

Baseline, 6 weeks and 12 weeks

Secondary outcome [1]

Telomere length measured in peripheral blood mononuclear cells isolated from whole blood and analysed using the qPCR technique.

Timepoint [1]

Baseline and 12 weeks.

Secondary outcome [2]

Telomerase activity measured using the repeat amplification protocol (TRAPeze 'registered trademark' ELISA Telomerase Detection Kit)

Timepoint [2]

Baseline and 12 weeks

Eligibility

Key inclusion criteria

(1) be aged greater than or equal to 60 years; and (2) have any one of the following conditions (indicating increased risk for CVD: i. diabetes; ii. diagnosed familial hypercholesterolaemia; iii. systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg; iv. serum total cholesterol greater than 7.5 mmol/L or any two of the following: i. current smoker; ii. waist circumference (greater than or equal to 94 cm men; greater than or equal to 80 cm women); iii. BMI (greater than or equal to 25.0 kg/m^2); iv. family history of CVD; and 3) a low intake of fish (less than 1 serving per week) or self-report to consume nuts and olive oil in amounts lower than the proposed Mediterranean style diet; (4) willing to consume 9 fish oil capsules per day or follow a diet containing foods high in antioxidants; (5) able to provide written informed consent; and (6) able to attend clinic visits at Flinders Medical Centre.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) unwilling to comply with study protocol; (2) diagnosed cardiovascular disease or suffered a CV event; (3) currently on a weight loss diet or actively trying to lose weight; (4) allergies to fish/seafood or components of the Mediterranean diet (e.g. nuts); (5) intake of anti-inflammatory medications on a regular basis or if an acute intake, within 1 week of clinic screening visit; and (6) currently taking fish oil.

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)

Participants will be randomized into one of three groups. Group 1 will follow a Mediterranean influenced antioxidant diet (provided 15g walnuts, 7.5g hazelnuts, and 7.5g almonds per day, pre-packed into weekly allowances, and 20ml virgin olive oil per day; commercially available from a large supermarket chain in Australia). Group 2 and Group 3 will consume a fish oil capsule supplemented diet (they will be provided with 9 capsules per day; Melrose, Australia, L156237), with either higher dose n-3 PUFA (~1.5g EPA and 1g DHA), or lower dose n-3 PUFA (containing 10% of the active dose; control). The contents of the fish oil capsules will be double blinded to participants and all study staff.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation schedule will be devised by an independent statistician using ralloc.ado version 3.6.1 in Strata version 11.1. Blocks of size 6, 9, and 12 were chosen at random and treatment allocations were randomly permuted and balanced within blocks.

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

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Statistical analyses will be performed using SPSS (SPSS 17.0 for Windows, SPSS Inc. Chicago, IL, USA). All baseline data were normal and were expressed as mean (+/-SD) values if continuous and frequency (%) if categorical. Comparisons between groups at baseline were made using the one way analysis of variance (ANOVA; with Tukey’s post hoc test) for independent groups for continuous variables and chi square tests for categorical variables. The level of significance was set at P<0.05 and two tailed P values were used.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/07/2012

Actual

27/07/2012

Date of last participant enrolment

Anticipated

Actual

14/01/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

Flinders University

Address

Flinders Medical Centre
Nutrition and Dietetics
Flinders Drive, Bedford Park
SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/06/2012

Ethics approval number [1]

224.12

Summary

Brief summary

Traditional risk markers of CVD include blood lipids, inflammatory markers, and endothelial function. However, shorter telomeres have recently been associated with increased levels of C-reactive protein, being overweight and obese, and increased odds for developing CHD, when measured in peripheral blood mononuclear cells.
Anti-inflammatory dietary habits have been associated with increased telomere length. Specifically, a low fat, high antioxidant diet, with an emphasis on high fruit, vegetable, wholegrain and legume intake, increased telomerase activity; and a small four week intervention of consumption of a Mediterranean diet was found to decrease the percentage of cells with telomere shortening. The Mediterranean diet is high in polyphenols, phytochemicals, and monounsaturated fatty acids that confers antioxidative properties to reduce oxidative stress and inflammation to protect the heart. Recent studies have observed that specific aspects of the diet such as nuts and/or olive oil is protective towards cardiovascular health, and may thus be extracted and incorporated into the diets of other populations. Thus, the association between shorter telomeres and CVD risk factors, and anti-inflammatory diets with telomere biology, suggest that components of diets with anti-inflammatory properties may reduce CVD risk by preventing the loss of telomere length and increasing telomerase activity. To date, no study has compared the effects of fish oil supplementation or a Mediterranean influenced Antioxidant (MAx) diet on telomere length and telomerase activity in the Australian population. Furthermore, while the tolerance and acceptability of fish oil has been studied, acceptability of Mediterranean dietary aspects in an Australian population has not been investigated in a randomised controlled trial. Therefore, investigation into this area is essential to assessing the feasibility of introducing these foods to the population due to the cardiovascular benefits that they accrue. 
This pilot study aims to identify (1) the adherence to fish oil and a MAx diet in older Australians and thus feasibility of such dietary interventions, and (2) areas for improvement in study design to aid the development of a larger six month study with 210 participants, which will investigate the effects of these dietary interventions on telomere length and telomerase activity.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jessica Grieger

Address

Flinders Medical Centre, Bedford Drive
Level 7, Nutrition and Dietetics
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 8204 7075

Fax

jessica.grieger@flinders.edu.au

Contact person for public queries

Name

Jessica Grieger

Address

School of Paediatrics and Reproductive Health
Robinson Institute
Lyell McEwin Hospital
Haydown Road, Elizabeth Vale, SA 5112

Country

Australia

Phone

+61 8 8313 2132

Fax

jessica.grieger@adelaide.edu.au

Contact person for scientific queries

Name

Jessica Grieger

Address

School of Paediatrics and Reproductive Health
Robinson Institute
Lyell McEwin Hospital
Haydown Road, Elizabeth Vale, SA 5112

Country

Australia

Phone

+61 8 8313 2132

Fax

jessica.grieger@adelaide.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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