Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000670572
Ethics application status
Approved
Date submitted
13/04/2015
Date registered
29/06/2015
Date last updated
2/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Different Fatty Acids on Metabolic Rate in Overweight Women
Scientific title
Effect of Different Fatty Acids on Metabolic Rate in Overweight Women
Secondary ID [1] 286521 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 294741 0
Condition category
Condition code
Diet and Nutrition 295026 295026 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-blind, randomised, placebo-controlled intervention trial designed to evaluate whether fish oil supplementation can positively impact on metabolic rate in overweight women. Forty volunteers will be recruited through public advertisements. Prior to the commencement of the study volunteers will complete a series of questionnaires and tests designed to assess general health, diet history and exercise habits. Participants will be randomly allocated to consume 5 x 1g capsules per day containing either vegetable oil (control group) or fish oil for the duration of the study. Participants in the control group will receive 5 x 1g capsules of vegetable oil. For participants randomised to the fish oil group, the amount of fish oil provided will be based on participants’ total body weight. Participants will receive 2-5 fish oil capsules (each capsule of fish oil contains 600mg of long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) with the remainder as vegetable oil, providing a total of 5 capsules per day. Possible combinations are therefore; Group 1: up to 65kg (BMI 25-27.5) --> 2 fish oil, 3 placebo, Group 2: 65.1-75kg (BMI 27.6-30) --> 3 fish oil, 2 placebo, Group 3: 75.1-85 (BMI 30.1-32.5) --> 4 fish oil, 1 placebo, Group 4: 85kg and over (BMI 32.6-35) --> 5 fish oil, no placebo. A supplement diary will be used to assess compliance. Participants will attend two study visits at baseline (week 0) and at completion of the intervention (week 6). During these visits each participant will have a series of non-invasive measurements taken which include height, weight, resting energy expenditure, fat oxidation and body fat. Blood samples will be collected at both visits and assessed for erythrocyte saturation of two key fatty acids, DHA and EPA
Intervention code [1] 291614 0
Treatment: Other
Comparator / control treatment
Corn oil supplements (5 x 1g/day)
Control group
Placebo

Outcomes
Primary outcome [1] 294785 0
Resting energy expenditure, measured using an indirect calorimeter
Timepoint [1] 294785 0
Baseline (week 0) and 6 weeks
Primary outcome [2] 294786 0
Body composition assessed using a Tanita scale
Timepoint [2] 294786 0
Baseline (week 0) and 6 weeks
Primary outcome [3] 295039 0
Fat oxidation, measured using an indirect calorimeter
Timepoint [3] 295039 0
Baseline (week 0) and 6 weeks
Secondary outcome [1] 314043 0
Incorporation of omega-3 (DHA and EPA i.e. the omega-3 Index) into erythrocytes will also be assessed via blood samples collected from participants
Timepoint [1] 314043 0
Baseline (week 0) and 6 weeks

Eligibility
Key inclusion criteria
1. Female
2. BMI between 25-35 kg/m2
3. Non-smoker (minimum 6 months of abstinence)
4. Weight stable (changes < 5kg) within the last 3 months
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current smokers and ex-smokers within the last 6 months
2. Consume >1g fish oil supplement/day within the last 3 months
3. Have undergone anticoagulant therapy in the past 3 months
4. Are taking other anti-platelet agents; bleeding disorders
5. Have a cardiac condition (including high blood pressure), asthma, thyroid disorders, chronic disease
6. Have changed medication in the last 3 months
7. Take vitamin, mineral or herbal supplementation that may impact on study outcomes
8. Consume >4 cups coffee/day or a high level of caffeine that in the opinion of the investigators will be unsuitable for this study
9. Suffer claustrophobia or a fear of enclosed spaces
10. Have gained or lost weight (> 5kg) within the last 3 months
11. Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study
12. Are pregnant or breastfeeding (due to changes in metabolic rate)
13. Are allergic to fish or fish products

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)
An external party will be doing the randomisation and therefore coding the samples as A and B. The research administering the capsules will only know that the sample is A or B and will not know which treatment this pertains to. Therefore the individual administering the capsules will be blinded, consistent with a double-blind placebo controlled intervention. The first person eligible for the study will be randomised toeither A or B using a simple coin-toss. Subsequent persons will be allocated to treatment groups via the process of randomisation by minimisation, with BMI and age balanced between groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatment groups will be via the process of randomisation by minimisation, with BMI and age balanced between 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a pilot study that will collect data that will be used for a power analysis for a subsequent study. We plan to recruit 40 participants for this pilot study. Analysis of variance (ANOVA) with repeated measures will be used to determine the effect of the treatments, time of measurement and their interactions on the dependent variables. Where ANOVA will show a statistically significant main effect, pair-wise comparisons will be performed using Tukey’s Honestly Significant Differences test to determine differences between means.
Individual changes in fat oxidation, resting energy expenditure and body fat will also be correlated against changes in erythrocyte LCn3PUFA content using Pearson correlations.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
11/05/2015
Actual
11/06/2015
Date of last participant enrolment
Anticipated
30/09/2016
Actual
7/07/2016
Date of last data collection
Anticipated
Actual
23/08/2016
Sample size
Target
40
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9516 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 291085 0
University
Name [1] 291085 0
University of South Australia
Country [1] 291085 0
Australia
Funding source category [2] 291263 0
Commercial sector/Industry
Name [2] 291263 0
EPAX
Country [2] 291263 0
Norway
Primary sponsor type
Individual
Name
Ass. Prof Alison Coates
Address
Division of Health Science
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Australia
Country
Australia
Secondary sponsor category [1] 289763 0
Individual
Name [1] 289763 0
Dr. Alison Hill
Address [1] 289763 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [1] 289763 0
Australia
Secondary sponsor category [2] 289764 0
Individual
Name [2] 289764 0
Dr. Sze Yen Tan
Address [2] 289764 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [2] 289764 0
Australia
Secondary sponsor category [3] 289765 0
Individual
Name [3] 289765 0
Mr. Lennie Shore
Address [3] 289765 0
Alliance for Research in Exercise, Nutrition and Activity,
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide SA 5001
Country [3] 289765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292667 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 292667 0
Ethics committee country [1] 292667 0
Australia
Date submitted for ethics approval [1] 292667 0
03/03/2015
Approval date [1] 292667 0
16/04/2015
Ethics approval number [1] 292667 0
0000034131

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56482 0
A/Prof Alison Coates
Address 56482 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 56482 0
Australia
Phone 56482 0
+61 8 8302 2313
Fax 56482 0
Email 56482 0
[email protected]
Contact person for public queries
Name 56483 0
Alison Coates
Address 56483 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 56483 0
Australia
Phone 56483 0
+ 61 8 8302 2313
Fax 56483 0
Email 56483 0
[email protected]
Contact person for scientific queries
Name 56484 0
Alison Coates
Address 56484 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 56484 0
Australia
Phone 56484 0
+ 61 8 8302 2313
Fax 56484 0
Email 56484 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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