ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12608000425392

Ethics application status

Approved

Date submitted

23/05/2008

Date registered

26/08/2008

Date last updated

14/06/2013

Type of registration

Retrospectively registered

Titles & IDs

Public title

N-3 fatty acids in diets for weight loss

Scientific title

Is a higher intake of omega-3 fatty acids advantageous for weight loss for overweight and obesity?

Secondary ID [1]

NHMRC #514631; the SMART trial

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Hypocaloric diet for 12 months +daily placebo capsules (1g olive oil)
2. Hypocaloric diet inclusive of 180gfish/week +daily placebo capsules (1g olive oil)
3. 2. Hypocaloric diet inclusive of 180gfish/week + oral fish oil capsules comprising 630 mg/day Long Chain polyunstaurated fatty acids (PUFA) (420 mg Eicosapentaenoic acid (EPA)+ 210 mg docosahexanoic acid (DHA) (Blackmore’s Promega Heart) daily for 12 months.
Dietary intervention comprises dietary education and follow-up provided by a dietitian. The first dietary counselling session is 1 hour and follow up sessions comprise 30 minutes. There are monthly consultations for the first 3 months, followed by 3-monthly consultations (ie at 6,9, and 12 months of follow-up).

Intervention code [1]

Lifestyle

Intervention code [2]

Other interventions

Comparator / control treatment

Hypocaloric low fat (30 % energy (%E) from total fat; 10 % E saturated fat; 15 % E monounstaurated fat; 5 % polyunsaturated fat) with or without advice to include 180g fish/weekdiet for 12 months + daily placebo capsules (1 g olive oil) Dietary intervention comprises dietary education and follow-up provided by a dietitian. The first dietary counselling session is 1 hour and follow up sessions comprise 30 minutes. There are monthly consultations for the first 3 months, followed by 3-monthly consultations (ie at 6,9, and 12 months of follow-up).

Control group

Active

Outcomes

Primary outcome [1]

Between-group differences in change from baseline in total percent body fat, measured using the bioelectrical impedance (Tanita TBF-622) and Dual Energy X-ray Absorptiometry (DEXA) techniques (Hologic QDR 4500 (Hologic Inc. Bedford MA)).

Timepoint [1]

3 months and 12 months

Primary outcome [2]

Between-group differences in change from baseline in body weight

Timepoint [2]

3 months and 12 months

Primary outcome [3]

Between-group differences in change from baseline in 24hr energy expenditure, measured in a whole room calorimeter.

Timepoint [3]

3 months and 12 months

Secondary outcome [1]

Between-group differences in change from baseline in substrate oxidation, measured in a whole room calorimeter

Timepoint [1]

3 months and 12 months

Secondary outcome [2]

Between-group differences in change from baseline in erythrocyte LC PUFA concentration (blood test).

Timepoint [2]

3 months and 12 months

Secondary outcome [3]

Between-group differences in change from baseline in blood pressure

Timepoint [3]

3 months and 12 months

Secondary outcome [4]

Between-group differences in change from baseline in heart rate

Timepoint [4]

3 months and 12 months

Secondary outcome [5]

Between-group differences in change from baseline in fasting leptin (Blood test)

Timepoint [5]

3 months and 12 months

Secondary outcome [6]

Between-group differences in change from baseline in insulin and glucose levels (blood tests).

Timepoint [6]

3 months and 12 months

Eligibility

Key inclusion criteria

Overweight or obese Body Mass Index (BMI) >25 and =< 37 kg/m2

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Major illnesses, diabetes mellitus, Low density lipoprotein (LDL) > 6 mmol/l, food allergies or habits inhibiting compliance, illiteracy and inadequate conversational English, inability to undertake study requirements, taking fish oil supplements, pregnancy/lactation, not weight stable for past six months (within 3kg), or on a weight-reducing diet

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)

Potential participants were drawn from the general public through media advertisements and promotions, emails and through flyers. Volunteers of the study underwent a screening interview and eligible participants attended an initial assessment at the University of Wollongong. Randomisation was performed centrally, off-site and and the holder of the allocation schedule provided the codes to a single researcher who was independent to the subject interface. The placebo and active ingredient capsules were coded off-site . The codes were kept from the researchers collecting dietary data and delivering treatment. Allocation concealment was maintained as the persons responsible for screening eligible participants for inclusion in the trial was unaware to which supplement group the subject would be allocated. Different dietitians collected the dietary data and provided dietary advice. Since dietary advice was given in terms of food groups, it was not possible to blind the dietitians but the subjects were not informed as to their diet group allocation.

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

A researcher independent of the subject interface undertook the randomisation of subjects into diet groups (stratified by sex and block randomised (nQuerry Advisor V 7.0 Statistical Solutions Cork, Ireland).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2008

Actual

8/07/2008

Date of last participant enrolment

Anticipated

25/11/2008

Actual

26/02/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2522

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

PO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Wollongong

Address

Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong NSW 2522

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Wollongong/Illawarra Area Health Service

Ethics committee address [1]

Human Research and Ethics Committee
University of Wollongong 
Northfields Avenue
Wollongong NSW 2522

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/12/2007

Ethics approval number [1]

HE07/323

Summary

Brief summary

This study aims to demonstrate that, in the long term, a hypocaloric diet supplemented with long chain polyunsaturated fat (LC PUFA) will be more beneficial for weight loss than a control hypocaloric diet for overweight individuals. Outcomes will be compared in those receiving general hypocaloric  dietary advice with those receiving the same advice but inclusive of 180g fish/week and LC PUFA (fish oil) supplements. We hypothesise that the intervention will produce positive outcomes for cardiovascular disease risk factors Potential mechanisms for the effect of the diet will be investigated

Trial website

Trial related presentations / publications

Tapsell LC, Batterham MJ, Charlton KE. Effect of dietary restriction and n-3PUFA supplementation on insulin resistance in obese adults. Experimental Biology FASEB J 2010:24:733.9
O’Shea J, et al (2010), Start date may predict attrition 6mo into a 12mo weight loss trial, Nutr & Diet,2010; 67:S53
Neale E, (2010) Baseline relationships between fish intakes and metabolic profiles appear different for males and females trial participants in a dietary intervention trial, Nutr & Diet,2010;67:S52
Zhang Q, et al, (2010), Baseline characteristics of volunteers in the SMART clinical trial: associations between habitual physical activity and lifestyle disease risk factors, Nutr & Diet2010;67:S67
Zhang Q et al (2010), 24-hour energy expenditure in healthy overweight subjects: agreement between prediction equations and indirect calorimetry, Nutr & Diet 2010;67:S14
Thorne R, et al (2010), ‘Fibre: Male participants not getting enough’, Nutr & Diet,2010;67:S12
Cossey A, et al (2010), Fish consumption in the SMART clinical trial, Nutr & Diet, 2010; 67:S30
Tapsell LC, et al Associations between baseline erythrocyte n-3 polyunsaturated fatty acids and weight indices in volunteers for a weight loss dietary intervention, Australasian Medical Journal,2010; 1 (1), pp 61
Neale EP, et al  Baseline fish consumption patterns in overweight volunteers participating in a trial examining dietary fat and weight loss, Australasian Medical Journal,2010; 1 (1), pp 61
Tapsell LC, Dietary methodology in clinical trials: changing dietary fat profiles. Australasian Med . ,2010; 1 (1), pp 70
Charlton K, et al Blood pressure is associated with markers of endogenous fat metabolism Austr Med J. 2010; 1 (1), pp 32
O’Shea JE, et al. Calcium – female study participants still not getting enough, Nutr & Diet 2009; 66 (Suppl 1) A53
Probst Y, et al  Relative validity of three different dietary assessment tools as part of a food-based clinical trial for weight loss, Nutr & Diet2009; 66 (Suppl 1)A25-A26
Thorne, RL et al. Developing dietary advice guidelines for food based clinical trials, Nutr & Diet2009; 66 (Suppl 1)A46-A47

Public notes

Contacts

Principal investigator

Name

Prof Linda Tapsell

Address

Smart Foods Centre
University of Wollongong NSW 2522

Country

Australia

Phone

+61 2 4221 3152

Fax

+61 2 4221 4844

ltapsell@uow.edu.au

Contact person for public queries

Name

LindaTapsell

Address

Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522

Country

Australia

Phone

02-4221 3152

Fax

02-4221 4844

ltapsell@uow.edu.au

Contact person for scientific queries

Name

LindaTapsell

Address

Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522

Country

Australia

Phone

02-4221 3152

Fax

02-4221 4844

ltapsell@uow.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Consumers' salient beliefs regarding dairy products in the functional food era: a qualitative study using concepts from the theory of planned behaviour	2011	https://doi.org/10.1186/1471-2458-11-843
Dimensions AI	Foods, nutrients or whole diets: effects of targeting fish and LCn3PUFA consumption in a 12mo weight loss trial	2013	https://doi.org/10.1186/1471-2458-13-1231
Embase	Baseline characteristics associated with different BMI trajectories in weight loss trials: A case for better targeting of interventions.	2016	https://dx.doi.org/10.1038/ejcn.2015.45
Embase	Identification of dietary patterns associated with blood pressure in a sample of overweight Australian adults.	2016	https://dx.doi.org/10.1038/jhh.2016.10

N.B. These documents automatically identified may not have been verified by the study sponsor.

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