Do omega-3 polyunsaturated fatty acids have a gender-specific effect on insulin resistance?

Do omega-3 polyunsaturated fatty acids have a gender-specific effect on insulin resistance? A double-blind randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000287437

Acronym

O3FA-IR

Enrollment

Registered

2016-03-04

Start date

2016-07-15

Completion date

2017-08-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Development of type 2 diabetes is closely linked with overweight and obesity. Due to the increasing prevalence of obesity in Australia, combined with an increasingly aged population, type 2 diabetes and associated health complications will become an increasingly burdensome public health problem in the near future. Epidemiological studies, as well as animal studies, suggest that a higher omega-3 status might be protective against obesity-related insulin resistance, however, intervention trials have had equivocal results. Recent evidence suggests that the effect of omega-3 polyunsaturated fatty acids on insulin resistance might be sex dependent. Therefore the aim of the current study is to determine whether there is a sex-dependent response on measures of insulin resistance to an omega-3PUFA intervention

Interventions

The intervention arm will receive 2 x 1g/day fish oil capsules (EPAX 1050 TG/N). Each capsule containing 60mg EPA + 430mg DHA for 12 weeks. Participants will be required to return unused tablets to assess compliance. In addition, omega-3 content in erythrocyte membranes will be measured at the start and the conclusion of the study in order to assess compliance.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age – 18-70; gender – both males and females 2. No participation in any clinical trial for at least 3 months 3. BMI between 25-45kg/m2 4. Waist Circumference > 88cm (females) and 102cm (males)

Exclusion criteria

1. Pregnancy or lactation 2. Established type 2 diabetes 3. Have an electronic implant (e.g. pacemaker) 4. Currently taking anti-diabetic medications 5. Allergic to seafood or corn 6. Currently on medication with Aspirin and Warfarin 7. History of gastro-intestinal disorders 8. History of severe neurological diseases or seizures 9. History of new investigational drug three months prior to this trial 10. Consuming more than 2 serve of oily fish per week 11. Taking regular dietary supplements known to influence blood glucose level 12. Unwilling to fast for 10hr before obtaining blood sample

Outcome results