None listed
Conditions
Brief summary
Aim: To test the efficacy of a strucured diet and lifestyle program for plasma cholesterol and weight reduction which can be used at point of care to reduce absolute cardiovascular risk and the need for lipid lowering drugs.
Interventions
The primary objective in this study is to develop a 6 week comprehensive diet and lifestyle intervention program (CLIP) targeted to achieve a cholesterol reduction comparable to a statin (S) and to compare this approach to standard lifestyle advice with (S+L) and without (L) statin therapy on plasma lipids and cardiovascular risk factors.
Group 1 CLIP Program (low saturated fat + sterols + soluble fibre + weight reduction + exercise).
Sponsors
CSIRO Human Nutrition
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 69 Years
Healthy volunteers
No
Inclusion criteria
1. Body Mass Index (BMI) >27; <40 kg/m2 (this will be calculated for you) 2. Serum cholesterol 5 – 8 mmol/L as previously assessed or identified at screening. 3. Not currently taking lipid lowering medication. 4. Be available for the duration of the study 5. Apparently healthy: no reported current or previous metabolic diseases, gastrointestinal disorders, renal or cardiovascular disease. 6. Serum liver enzymes ALAT, ASAT, y-GT and bilirubin within normal reference range at screening. 7. Walk independently and able to perform physical activity without pain 8. No history of coronary artery disease or cardiac (heart) abnormalities.
Exclusion criteria
1. Reported medical treatment that may affect lipid metabolism.12. Family history of hypercholesterolemia.13. Type 1 (self reported)14. High alcohol consumption > 21 standard drinks/week (female subjects) or > 28 standard drinks/week (male subjects).15. Reported lactating, pregnant or wish to become pregnant during the study. If the volunteer becomes pregnant during the trial they will be withdrawn. The use of sterol containing products during pregnancy is not a risk for mother or baby.16. The following items if taken need to be kept stable during the study: corticosteroids, diuretics, B-blockers, fish oil supplements17. Frequent dining out (> 5X/week and unable to cease)18. Inability to prepare meals or meet diet requirements19. Extended absences due to travel or other commitments20. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
Outcome results
None listed