An interventional study of Dietary portfolio of cholesterol-lowering foods in Hyperlipidemia, Cardiovascular Diseases and Hypercholesterolemia, sponsored by University of Toronto. Completed at 1 site in Canada. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by University of Toronto · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the long term effectiveness of the dietary portfolio, consisting of viscous fibers, soy products, nuts and plant sterols, as well as the effects of removing single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors.
We have shown in 1-month metabolic studies that a dietary portfolio, consisting of soy products, viscous fibers, almonds and plant sterols in the form of margarine, can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). However, the long-term effectiveness of the dietary portfolio is not known. Furthermore, it is not known to what extent each of the food components contribute to the cholesterol reductions observed. We wish to therefore evaluate the long term effects of the dietary portfolio as well as the effects of removing single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors. We believe the removal of single food components will result in a reduction of the cholesterol-lowering effect to a similar extent as predicted with the cholesterol reductions observed when the food component is consumed alone.
Method:
66 subjects will be recruited for a 6-month to 5 year long-term dietary portfolio study with the option for continuation (re-consenting) at the end of 6, 12 or 24 months. The active dietary components consist of viscous fibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol-enriched margarine). Lipids, blood pressure, body weight, and routine biochemical and hematology analyses will be performed over the 5 year period, with lipids and blood pressure measured at 2 monthly intervals. 40-50 subjects on the long term dietary portfolio study, all of whom will have been on the diet for at least 1 year, will be asked to remove a specific food component from their regular dietary portfolio for a 10 week period. After the 10 week period, subjects will be asked return to the normal dietary portfolio with all food components consumed and continue on the long-term dietary portfolio.
Bloods will be taken at weeks 0, 6 and 10 of the food component removal period; and at 2-monthly intervals for 20 weeks prior to and after the 10 week period while on the long-term dietary portfolio with all food components.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 66 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Dietary advice to consume a dietary portfolio of cholesterol-lowering foods
Dietary Supplement: Dietary portfolio of cholesterol-lowering foods
A plant based dietary portfolio providing plant sterols (1.0g/1000 kcal), soy protein (22.5g/1000 kcal, viscous fibers 10 g/1000 kcal and almonds 22.5g/1000 kcal)
Total cholesterol
Time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
LDL cholesterol
Time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
C-reactive protein
Time frame: At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years
Blood pressure
Time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Body Weight
Time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Apolipoprotein A1 and B
Time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Lp(a)
Time frame: At weeks 0, 24, 52; then every 6 months to a total of 5 years
Routine Biochemistry and hematology measurements
Time frame: At week 0, 12, 24 and every 6 months to 5 years
Compliance to dietary portfolio components
Time frame: At years, 1, 2, 3, 4 and 5
24 hour urinary markers and electrolytes (optional)
Time frame: At week 0 and end of years 1, 2, 3, 4 and 5
Oxidative stress markers
Time frame: week 0 and every 6 months to 5 years
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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