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

Not Applicable

Recruiting

• Conditions: Insulin Resistance; Obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000287437
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin Resistance (i.e. HOMA-IR, Matsuda Index)<br>HOMA-IR will be calculated using fasting plasma glucose and fasting plasma insulin measures. Matsuda Index will be calculated following a 2 hour Oral Glucose Tolerance Test, using plasma glucose and insulin values obtained at 0 mins and 120 mins post OGTT.[Baseline (week 0) and post intervention (week 12)];Glycemic Profile (i.e. fasting plasma glucose, fasting plasma insulin, HbA1c in whole blood)[Baseline (week 0) and post intervention (week 12)]

Secondary Outcome Measures

Name	Time	Method
Inflammatory Profile (i.e. CRP, TNF-alpha, IL-6, IL-1beta, adiponectin in blood serum)[Baseline (week 0) and post intervention (week 12)];Erythrocyte Fatty Acid Composition. (Fatty acid composition of erythrocyte plasma membranes, assessed via Gas Chromatography)[Baseline (week 0) and post intervention (week 12)];Lipid Profile (i.e. total cholesterol, LDL, HDL, TG in blood serum)[Baseline (week 0) and post intervention (week 12)]