Fatty acid metabolism and heart disease

A randomised trial to evaluate the effects of weight loss in the treatment of the metabolic syndrome on Cytochrome P-450 metabolites of Arachidonic acid

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000107628

Enrollment

Registered

2005-08-09

Start date

2005-02-20

Completion date

2006-06-06

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

Overweight people are at risk of developing heart disease due to their predisposition of also having high blood pressure, high blood fats and high blood sugar levels. This project examines the role of certain fatty acid metabolites called cytochrome P450 metabolites of arachidonic acid (CYP-450AA) in conditions associated with being overweight. These fatty acid metabolites act on blood vessels causing them to constrict or dilate. In doing this they affect blood pressure regulation. Being overweight or obese makes people vulnerable to developing diabetes and cardiovascular disease. This study will examine CYP-450AA in overweight men and women before and after weight reduction compared with overweight volunteers who maintain their weight over the same time period. This will enable us to see if the levels of fatty acid metabolites that constrict blood vessels are altered and related to a fall in blood pressure after weight reduction. This project will help scientists decide how important these metabolites are for blood pressure regulation in overweight people.

Interventions

The intervention group will receive dietary counselling to reduce their energy intake by 2000-6500 kJ /day aiming to achieve a 5-8kg wight loss during the first 12 weeks. This will be followed by 12 weeks of stabilisation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

Men aged 20-70 years and women (post-menopausal not taking hormone replacement therapy) who are non-smokers and not taking medication will be recruited if they have a waist circumference > 102cm males, > 88cm females and blood pressure >120/85 mmHg In addition they may also have the following National Cholesterol Education Program (NECP) criteria :- triglycerides > 1.7 mol/l; HDL-C <1.04 males, <1.3 females; fasting glucose > 6.1.

Exclusion criteria

No exclusion criteria

Outcome results