2006 Cholesterol challenge Study

Phase 4

Recruiting

• Conditions: Hypercholesterolaemia; Blood - Other blood disorders

• Registration Number: ACTRN12606000127505
• Lead Sponsor: CSIRO Human Nutrition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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 If the volunteer becomes pregnant during the trial they will be withdrawn.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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight and waist circumference[Measured at week 0 and week 6];Fasting Lipids (Total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (calculated))[Measured at week 0 and week 7];Blood Pressure[Measured at week 0 and week 8];Fasting Glucose and Insulin[Measured at week 0 and week 9];Plasma Carotenoids[Measured at week 0 and week 10];Plasma C Reactive protein[Measured at week 0 and week 11];Plasma folate, homocysteine, vitamin B12[Measured at week 0 and week 12]

Secondary Outcome Measures

Name	Time	Method
Baseline diet and ongoing diet assessment[Measured at week 0 and week 6.];Fitness assessment[Measured at week 0 and week 6.];Subjective assessments of diet intervention plus barriers and facilitators[Measured at week 0 and week 6.];Genotyping[Measured at week 0 and week 6.];Psychological assessments[Measured at week 0 and week 6.];Psychological well being (GHQ-12) [Measured at week 0 and week 6.];Self esteem (RSE-B)[Measured at week 0 and week 6.];Barriers and facilitators [Measured at week 0 and week 6.];General Health[Measured at week 0 and week 6.];Personal need for structure[Measured at week 0 and week 6.]