The Effect of Fish Oil Oral Supplementation on Fat Metabolism in Obese Subjects on a Weight Loss Diet.

Phase 4

• Conditions: Dyslipidaemia; Metabolic and Endocrine - Metabolic disorders; Diet and Nutrition - Obesity

• Registration Number: ACTRN12610000750088
• Lead Sponsor: Professor Gerald Watts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Men and post-menopausal women aged 18-75 with Body Mass Index less than 45kg/m2 will be recruited. Post Menopausual will be defined by: no menstrual cycle for 1 year and Follicle Stimulating Hormone (FSH) greater than 30U/L, or if the subject has had a hysterectomy or surgical sterilisation. Central obesity will be defined as waist circumference greater than 88cm for women and greater than 102cm for men AND triglycerides greater than or equal to 1.5mmol/L and/or High-Density-Lipoprotein (HDL) cholesterol less than 1.0mmol/L for men and less than 1.3mmol/L for women.

Exclusion Criteria

Subjects with genetic hyperlipidemia, (eg Familial Hyperlipidemia, type III), Total cholesterol greater than 7mmol/L, proteinuria, hypothyroidism, alcoholism (greater than 30grams/day), creatinaemia (greater than 130micromol/L), hepatic dysfunction (Aspartate Transaminase (AST) or Alinine Transaminase (ALT) greater than 3 times the Upper Limit of Normal (ULN) and major systemic illness; pre-menopause women; use of steroids or other agents that may influence lipid metabolism, cardiovascular event within past 6 months, use of hypocaloric diets, anaemia; a history of intolerance to fish oil. Any gasto-intestinal surgery that would affect intestinal transit time and interpretation of postprandial lipaemia. Diabetics on medical management.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To examine the effect of n-3 fatty acid ethyl esters oral supplementation on Very-Low-Density-Lipoprotein (VLDL) transport in the background of weight loss. VLDL transport will be determined through blood analysis and compared between the two groups. All analysis will be carried out using Statistical Package for the Social Sciences (SPSS). Associations will be examined using simple regression method. Paired T-tests will be used to assess changes within both treatment groups for all variables. Differences between the groups prior to randomistation will be determined by one-way Analysis of Variance (ANOVA). Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.[VLDL transport time points are baseline, 5, 10, 20, 30, 40, 60 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 24 hours following administration of D3-Leucine stable isotope and vitamin A capsules on 2 occasions. i.e. the beginning and end of the 16 weeks treatment period.]

Secondary Outcome Measures

Name	Time	Method
Markers of triglyceride-rich lipoprotein (triglycerides, apoB-48, retinyl palmitate) through blood analysis.[Baseline, 5, 10, 20, 30, 40, 60 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 24 hours following administration of D3-Leucine stable isotope and vitamin A capsules on 2 occasions. i.e. the beginning and end of the 16 weeks treatment period.];Forearm plethysmography: changes in forearm blood flow[The beginning and end of the 16 weeks treatment period.];Non-invasive measures of arterial stiffness (applanation tonometry and arterial pulse wave analysis)[The beginning and end of the 16 weeks treatment period.]