ACTRN12606000127505
Recruiting
Phase 4
Comprehensive Lifestyle Intervention Program (CLIP) compared to Statin Therapy plus standard lifestyle advice in managing lipids and CVD risk in individuals with hypercholesterolaemia
CSIRO Human Nutrition0 sites150 target enrollmentApril 7, 2006
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hypercholesterolaemia
- Sponsor
- CSIRO Human Nutrition
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 If the volunteer becomes pregnant during the trial they will be withdrawn.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.
Outcomes
Primary Outcomes
Not specified
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