None listed
Conditions
Brief summary
The aim of this study is to examine the effect of weight loss plus oral supplementation of Omacor (Fish Oil) on postprandial lipid and lipoprotein transport in obese subjects. We hypothesis that in obese subjects, triglyceride production will be further reduced with Omacor oral supplementation in addition to weight loss in the postprandial state. All eligible participants will be on a weight loss period for 12 weeks followed by a weight maintanence period of 4 weeks. During these 16 weeks, each participant will be randomised into either weight loss alone (Group 1) or weight loss plus Omacor oral supplementation (Group 2).
Interventions
2 parallel groups.
Group 1 - Weight loss alone. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a dietitian face-to-face every 2 weeks (each session approximately 30-60minutes) for professional dietary advice.
Group 2 - Weight loss plus Fish Oil. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a die
2 parallel groups. Group 1 - Weight loss alone. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a dietitian face-to-face every 2 weeks (each session approximately 30-60minutes) for professional dietary advice. Group 2 - Weight loss plus Fish Oil. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a dietitian face-to-face every 2 weeks (each session approximately 30-60minutes) for professional dietary advice. Throughout this 16 weeks period, participants will also be provided with n-3 fatty acid ethyl esters (Fish Oil) oral supplementation (4g/day) to be consumed daily.
Sponsors
Professor Gerald Watts
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed