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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] 253474 0
NHMRC #514631; the SMART trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 3184 0
Condition category
Condition code
Diet and Nutrition 3346 3346 0 0
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] 2916 0
Lifestyle
Intervention code [2] 2917 0
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] 4235 0
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] 4235 0
3 months and 12 months
Primary outcome [2] 4236 0
Between-group differences in change from baseline in body weight
Timepoint [2] 4236 0
3 months and 12 months
Primary outcome [3] 4237 0
Between-group differences in change from baseline in 24hr energy expenditure, measured in a whole room calorimeter.
Timepoint [3] 4237 0
3 months and 12 months
Secondary outcome [1] 7154 0
Between-group differences in change from baseline in substrate oxidation, measured in a whole room calorimeter
Timepoint [1] 7154 0
3 months and 12 months
Secondary outcome [2] 7155 0
Between-group differences in change from baseline in erythrocyte LC PUFA concentration (blood test).
Timepoint [2] 7155 0
3 months and 12 months
Secondary outcome [3] 7156 0
Between-group differences in change from baseline in blood pressure
Timepoint [3] 7156 0
3 months and 12 months
Secondary outcome [4] 7157 0
Between-group differences in change from baseline in heart rate
Timepoint [4] 7157 0
3 months and 12 months
Secondary outcome [5] 7158 0
Between-group differences in change from baseline in fasting leptin (Blood test)
Timepoint [5] 7158 0
3 months and 12 months
Secondary outcome [6] 7159 0
Between-group differences in change from baseline in insulin and glucose levels (blood tests).
Timepoint [6] 7159 0
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
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 865 0
2522

Funding & Sponsors
Funding source category [1] 3422 0
Government body
Name [1] 3422 0
National Health and Medical Research Council (NHMRC)
Country [1] 3422 0
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] 3065 0
None
Name [1] 3065 0
Address [1] 3065 0
Country [1] 3065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5445 0
University of Wollongong/Illawarra Area Health Service
Ethics committee address [1] 5445 0
Human Research and Ethics Committee
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Ethics committee country [1] 5445 0
Australia
Date submitted for ethics approval [1] 5445 0
Approval date [1] 5445 0
18/12/2007
Ethics approval number [1] 5445 0
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 28613 0
Prof Linda Tapsell
Address 28613 0
Smart Foods Centre
University of Wollongong NSW 2522
Country 28613 0
Australia
Phone 28613 0
+61 2 4221 3152
Fax 28613 0
+61 2 4221 4844
Email 28613 0
ltapsell@uow.edu.au
Contact person for public queries
Name 11770 0
Prof LindaTapsell
Address 11770 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 11770 0
Australia
Phone 11770 0
02-4221 3152
Fax 11770 0
02-4221 4844
Email 11770 0
ltapsell@uow.edu.au
Contact person for scientific queries
Name 2698 0
Prof LindaTapsell
Address 2698 0
Smart Foods Centre
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 2698 0
Australia
Phone 2698 0
02-4221 3152
Fax 2698 0
02-4221 4844
Email 2698 0
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
SourceTitleYear of PublicationDOI
EmbaseBaseline characteristics associated with different BMI trajectories in weight loss trials: A case for better targeting of interventions.2016https://dx.doi.org/10.1038/ejcn.2015.45
EmbaseIdentification of dietary patterns associated with blood pressure in a sample of overweight Australian adults.2016https://dx.doi.org/10.1038/jhh.2016.10
Dimensions AIFoods, nutrients or whole diets: effects of targeting fish and LCn3PUFA consumption in a 12mo weight loss trial2013https://doi.org/10.1186/1471-2458-13-1231
Dimensions AIConsumers' salient beliefs regarding dairy products in the functional food era: a qualitative study using concepts from the theory of planned behaviour2011https://doi.org/10.1186/1471-2458-11-843
N.B. These documents automatically identified may not have been verified by the study sponsor.