RecruitingPhase 4ACTRN12606000127505

2006 Cholesterol challenge Study

Comprehensive Lifestyle Intervention Program (CLIP) compared to Statin Therapy plus standard lifestyle advice in managing lipids and CVD risk in individuals with hypercholesterolaemia


Sponsor

CSIRO Human Nutrition

Enrollment

150 participants

Start Date

Mar 27, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 69 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured diet and lifestyle program can lower cholesterol and reduce weight, potentially reducing the need for cholesterol-lowering medications. Participants will follow a guided program and have their cholesterol, weight, and overall heart health tracked over the study period. You may be eligible if: - You are between 20 and 69 years old - Your BMI is between 27 and 40 kg/m² - Your blood cholesterol is between 5 and 8 mmol/L - You are not currently taking cholesterol-lowering medication - You are generally healthy with no metabolic, kidney, or cardiovascular disease - Your liver enzyme levels are within normal range - You can walk independently and exercise without pain - You have no history of heart disease You may NOT be eligible if: - You take medications that affect fat metabolism - You have a family history of high cholesterol (inherited hypercholesterolaemia) - You have type 1 diabetes - You drink heavily (more than 21 standard drinks/week for women, 28 for men) - You are pregnant, breastfeeding, or planning to become pregnant - You eat out frequently (more than 5 times per week) and cannot reduce this - You are unable to prepare meals or follow a dietary plan Talk to your doctor about whether this trial might be right for you.

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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 c

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).


Locations(1)

Australia

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