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 个研究点目标入组 150 人开始时间: 2006年4月7日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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 If the volunteer becomes pregnant during the trial they will be withdrawn.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.

发起方

CSIRO Human Nutrition