The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001078347
Ethics application status
Approved
Date submitted
20/07/2017
Date registered
25/07/2017
Date last updated
12/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil in pregnancy for a healthy start to life for the children of overweight mothers
Scientific title
Omega-3 supplementation during pregnancy to improve metabolic health in the children of obese mothers
Secondary ID [1] 292470 0
None
Universal Trial Number (UTN)
U1111-1199-5860
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal obesity 304095 0
Childhood obesity 304096 0
Metabolic dysfunction in childhood 304097 0
Condition category
Condition code
Metabolic and Endocrine 303432 303432 0 0
Other metabolic disorders
Diet and Nutrition 303457 303457 0 0
Obesity
Reproductive Health and Childbirth 303479 303479 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 grams of n-3 PUFA rich fish oil taken in capsules on each day of pregnancy and for 3 months during the breastfeeding period. Note that if the mother chooses to stop breastfeeding then supplementation will stop early, this will be at birth if the mother decides not to breastfeed at all. Compliance will be assessed by return of unused capsules, and secondarily by measurement of n-3 PUFA levels in maternal red blood cells. Note that the expected concentration of n-3 PUFAs in this oil is 33% EPA/22% DHA, but this will be independently verified.
Intervention code [1] 298655 0
Treatment: Other
Intervention code [2] 298671 0
Prevention
Comparator / control treatment
3 grams of olive oil taken in capsules on each day of pregnancy and for 3 months during the breastfeeding period (if the mother chooses to breastfeed)
Control group
Placebo

Outcomes
Primary outcome [1] 302811 0
Whole body percentage body fat, as measured by dual x-ray absorptiometry (DXA) scan (in the offspring)
Timepoint [1] 302811 0
2 weeks of age
Secondary outcome [1] 337123 0
Peripheral quantitative computed tomography derived measures of bone strength from the lower Tibia (in the offspring)
Timepoint [1] 337123 0
2 weeks of age
Secondary outcome [2] 337124 0
Birth weight
Timepoint [2] 337124 0
At birth
Secondary outcome [3] 337127 0
Whole body percentage body fat, measured by DXA scan (in the offspring)
Timepoint [3] 337127 0
at 3 months of age
Secondary outcome [4] 337128 0
HOMA-IR (in the offspring)
Timepoint [4] 337128 0
3 months of age
Secondary outcome [5] 337129 0
Weight in the offspring
Timepoint [5] 337129 0
12 months of age
Secondary outcome [6] 337130 0
HOMA-IR (in the mother)
Timepoint [6] 337130 0
At 30 weeks of pregnancy
Secondary outcome [7] 337177 0
Ponderal Index (in the offspring)
Timepoint [7] 337177 0
12 months of age
Secondary outcome [8] 337178 0
Insulin sensitivity as determined by a modified IVGTT with minimal modelling (offspring)
Timepoint [8] 337178 0
4-7 years of age

Eligibility
Key inclusion criteria
Pregnant women, with BMI 30-45, singleton pregnancy, between 12-16 weeks of gestation
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current use of tobacco or nicotine, illicit drugs or medications that influence blood pressure, lipid metabolism or insulin sensitivity. Having diabetes mellitus or chronic illnesses such as autoimmune disease or malignancy.

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)
Allocation will involve contacting the holder of the allocation schedule who is not involved in recruitment, carrying out or analyzing the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Women who develop gestational diabetes will exit the study at the time of diagnosis of GDM and will not have any further assessments of themselves or their baby.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Treatment evaluation will be based on intention to treat. General linear regression models will be used to evaluate the treatment effect on the primary outcome and other offspring measures between the two treatment groups, adjusting for maternal BMI at study entry, maternal ethnicity and parity, gestational age at birth, and offspring gender. Statistical analyses will be performed in SAS v9.4 (SAS Institute Inc., Cary, NC, USA). Statistical tests will be two-tailed and significance maintained at 5%, without adjustment for multiple testing. Missing data will not be imputed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9067 0
New Zealand
State/province [1] 9067 0
Auckland

Funding & Sponsors
Funding source category [1] 297036 0
Government body
Name [1] 297036 0
A Better Start National Science Challenge, Funded by the Ministry of Business, Innovation and Employment
Address [1] 297036 0
Ministry of Business, Innovation and Employment
PO Box 1473
Wellington 6140
Country [1] 297036 0
New Zealand
Funding source category [2] 297041 0
Charities/Societies/Foundations
Name [2] 297041 0
Cure Kids
Address [2] 297041 0
PO Box 90 907
Victoria Street West
Auckland 1142
Country [2] 297041 0
New Zealand
Funding source category [3] 297042 0
Government body
Name [3] 297042 0
Health Research Council
Address [3] 297042 0
PO Box 5541
Wellesley Street
Auckland 1141
Country [3] 297042 0
New Zealand
Primary sponsor type
University
Name
Liggins Institute, University of Auckland
Address
Private bag 92019
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 296040 0
None
Name [1] 296040 0
None
Address [1] 296040 0
None
Country [1] 296040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298221 0
Health and Disability Ethics Committees (New Zealand)
Ethics committee address [1] 298221 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298221 0
New Zealand
Date submitted for ethics approval [1] 298221 0
01/08/2017
Approval date [1] 298221 0
03/10/2017
Ethics approval number [1] 298221 0

Summary
Brief summary
In New Zealand the majority of men (71%) and women (60%) are now overweight or obese. Obesity leads to cardiovascular disease, type 2 diabetes and some cancers, which are among the world’s greatest health problems. Within NZ, Maori, Pasifika and those who are poorer are more greatly affected.

Most women of reproductive age are also overweight or obese (60%). This is important as the offspring of women who are obese have alterations in the way their metabolism works that increase the chance that they will be a large baby, become overweight and eventually develop diabetes and cardiovascular disease. When these babies are born, they are already at a health disadvantage. The underlying problem is that insulin, the hormone that controls blood sugar works less well in their bodies.

I have shown in rats, that supplementing obese mothers with fish oil can prevent the offspring from developing problems with insulin action as they age. If this treatment had the same effect in humans, pregnant women could use it to reduce their unborn child’s lifetime risk of disease. This is a treatment that is already easily available in stores, so that it would be easy for women to take up.

We will enrol women into a clinical trial where they are randomised to take either fish oil, or a placebo (capsules with ordinary olive oil) on every day of pregnancy and the first 3 months of breastfeeding. When the baby is born we will measure its body fat using a special scan (at two weeks of age). We will reassess the baby again at 3 months and 12 months of age. We will keep in contact over time, and when the child is 4-7 years old we will perform a detailed assessment of the child’s metabolism, including assessing insulin action.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76386 0
Dr Benjamin Albert
Address 76386 0
Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 76386 0
New Zealand
Phone 76386 0
+64 9 923 6691
Fax 76386 0
+64 9 373 8763
Email 76386 0
b.albert@auckland.ac.nz
Contact person for public queries
Name 76387 0
Dr Benjamin Albert
Address 76387 0
Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 76387 0
New Zealand
Phone 76387 0
+64 9 923 6691
Fax 76387 0
+64 9 373 8763
Email 76387 0
b.albert@auckland.ac.nz
Contact person for scientific queries
Name 76388 0
Dr Benjamin Albert
Address 76388 0
Liggins Institute, University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
Country 76388 0
New Zealand
Phone 76388 0
+64 9 923 6691
Fax 76388 0
+64 9 373 8763
Email 76388 0
b.albert@auckland.ac.nz

No data has been provided for results reporting
Summary results
Not applicable