Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000127505
Ethics application status
Approved
Date submitted
23/03/2006
Date registered
7/04/2006
Date last updated
7/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
2006 Cholesterol challenge Study
Scientific title
Comprehensive Lifestyle Intervention Program (CLIP) compared to Statin Therapy plus standard lifestyle advice in managing lipids and CVD risk in individuals with hypercholesterolaemia
Secondary ID [1] 255 0
KK39A
Universal Trial Number (UTN)
Trial acronym
Clip
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 1092 0
Condition category
Condition code
Blood 1173 1173 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 952 0
Lifestyle
Comparator / control treatment
Group 2 Standard qualitative advice.
Group 3 Standard qualitative advice + simvastatin (20mg).
Control group
Placebo

Outcomes
Primary outcome [1] 1577 0
Weight and waist circumference
Timepoint [1] 1577 0
Measured at week 0 and week 6
Primary outcome [2] 1578 0
Fasting Lipids (Total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (calculated))
Timepoint [2] 1578 0
Measured at week 0 and week 7
Primary outcome [3] 1579 0
Blood Pressure
Timepoint [3] 1579 0
Measured at week 0 and week 8
Primary outcome [4] 1580 0
Fasting Glucose and Insulin
Timepoint [4] 1580 0
Measured at week 0 and week 9
Primary outcome [5] 1581 0
Plasma Carotenoids
Timepoint [5] 1581 0
Measured at week 0 and week 10
Primary outcome [6] 1582 0
Plasma C Reactive protein
Timepoint [6] 1582 0
Measured at week 0 and week 11
Primary outcome [7] 1583 0
Plasma folate, homocysteine, vitamin B12
Timepoint [7] 1583 0
Measured at week 0 and week 12
Secondary outcome [1] 2860 0
Baseline diet and ongoing diet assessment
Timepoint [1] 2860 0
Measured at week 0 and week 6.
Secondary outcome [2] 2861 0
Fitness assessment
Timepoint [2] 2861 0
Measured at week 0 and week 6.
Secondary outcome [3] 2862 0
Subjective assessments of diet intervention plus barriers and facilitators
Timepoint [3] 2862 0
Measured at week 0 and week 6.
Secondary outcome [4] 2863 0
Genotyping
Timepoint [4] 2863 0
Measured at week 0 and week 6.
Secondary outcome [5] 2864 0
Psychological assessments
Timepoint [5] 2864 0
Measured at week 0 and week 6.
Secondary outcome [6] 2865 0
Psychological well being (GHQ-12)
Timepoint [6] 2865 0
Measured at week 0 and week 6.
Secondary outcome [7] 2866 0
Self esteem (RSE-B)
Timepoint [7] 2866 0
Measured at week 0 and week 6.
Secondary outcome [8] 2867 0
Barriers and facilitators
Timepoint [8] 2867 0
Measured at week 0 and week 6.
Secondary outcome [9] 2868 0
General Health
Timepoint [9] 2868 0
Measured at week 0 and week 6.
Secondary outcome [10] 2869 0
Personal need for structure
Timepoint [10] 2869 0
Measured at week 0 and week 6.

Eligibility
Key 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.
Minimum age
20 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not formally blinded but participants unaware of alternative interventions. Volunteers will be randomly allocated by computer generated sequence to study treatments.The treatments are coded numerically. Locked comuter files indicate treatment allocation numerically and the treatment code is concealed from research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be initially blocked matched into 3 groups based on age, body mass index and gender, cholesterol level prior to randomisation by computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
6 week duration
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1282 0
Government body
Name [1] 1282 0
CSIRO
Country [1] 1282 0
Australia
Primary sponsor type
Government body
Name
CSIRO Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 1135 0
None
Name [1] 1135 0
n/a
Address [1] 1135 0
Country [1] 1135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2618 0
CSIRO Human Nutrition
Ethics committee address [1] 2618 0
Ethics committee country [1] 2618 0
Australia
Date submitted for ethics approval [1] 2618 0
Approval date [1] 2618 0
06/12/2005
Ethics approval number [1] 2618 0
05/26

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36080 0
Address 36080 0
Country 36080 0
Phone 36080 0
Fax 36080 0
Email 36080 0
Contact person for public queries
Name 10141 0
Dr Manny Noakes
Address 10141 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10141 0
Australia
Phone 10141 0
+61 8 83038827
Fax 10141 0
+61 8 83038899
Email 10141 0
manny.noakes @csiro.au
Contact person for scientific queries
Name 1069 0
Dr Manny Noakes
Address 1069 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1069 0
Australia
Phone 1069 0
+61 8 83038827
Fax 1069 0
+61 8 83038899
Email 1069 0
manny.noakes @csiro.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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