Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438425
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2007-02-21
Brief Title:
Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Assessment of the Practical Application Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors If potent lipid-lowering effects through novel dietary interventions can be demonstrated then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease
Aims
To determine the percentage of lipid clinic attendees interested in making a serious dietary change
To determine the extent to which a self selected dietary portfolio combining viscous fiber foods oat barley β-glucan psyllium etc soy and vegetable protein foods soy milk soy meat analogues and almonds and plant sterols sterol margarine in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice
To determine whether this effect can be maximized by more frequent follow-up and what if any would be the relationship between dietary compliance and reduction in LDL-C
Aims
To determine the percentage of lipid clinic attendees interested in making a serious dietary change
To determine the extent to which a self selected dietary portfolio combining viscous fiber foods oat barley β-glucan psyllium etc soy and vegetable protein foods soy milk soy meat analogues and almonds and plant sterols sterol margarine in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice
To determine whether this effect can be maximized by more frequent follow-up and what if any would be the relationship between dietary compliance and reduction in LDL-C
Detailed Description:
This is a randomized parallel study with three experimental arms of 6 months duration to estimate the effect of the portfolio diet under real world conditions at two levels of advice intensity Every effort will be made to obtain study blood samples and other data from all subjects at the designated times regardless of compliance with the dietary aspects of the study protocol All subjects will be used in the intent-to-treat analysis
Four Canadian Centers will be involved Vancouver Toronto Manitoba and Quebec City The study will be partially blinded The investigators and technical staff will be blinded but the dietitians and the patients will not be owing to the differences in taste and appearance of the study foods The blinding of physicians at clinic visits is likely to be difficult due to the requirement to ask questions related to diet All patients referred to the four collaborating clinics will be asked whether they would be prepared to modify their diet if that may mean they might lower their blood cholesterol without the use of drugs Those who checked the box for No or only modest dietary change would not be considered further Those who checked the box for significant or radical dietary change would be invited to participate providing they are not at high risk 20 10 yr risk of CHD and were within 30 of their target LDL-C concentrations according to current Canadian Working Group recommendations ie those who would normally be considered for a preliminary test of diet The three groups would be randomized to either a low saturated fat low cholesterol diet Step 2 or a portfolio diet both given as routine clinical advice at week zero with follow up at 3 and 6 months or more intensive advice reinforced intensive portfolio at clinic visits at 2 4 8 12 16 and 20 weeks In the routine portfolio the advice will therefore consist of two half hour sessions with the dietitian 0 and 12 weeks compared to seven for the intensive portfolio 0 2 4 8 12 16 and 20 weeks Prior to starting each diet the nature of the diet will be explained to the participants and instruction on achieving diet goals will be given Follow-up visits will be used to go over the subjects diet record which they have recorded over the previous 7 days and reinforce the original dietary advice The intensive portfolio participants will therefore receive five additional instructional and assessment follow up visits during the course of the study
Trial treatments The portfolio dietary advice will conform to current therapeutic diets appropriate for hypercholesterolemic subjects 7 of energy saturated fat 200 mgd cholesterol plus the combination of viscous fibers soy protein plant sterols and almonds The portfolio diet plan will include foods which contribute 8 g1000 kcal viscous fiber as β-glucan oats barley oat bran breads and soups and psyllium cereal 1 g plant sterol1000 kcal diet in sterol margarine 22 g soy protein1000 kcal soy burgers dogs links other meat analogues milks yogurts and cheese and 22 g almonds1000 kcal The Step 2 therapeutic diet will encourage a similar macronutrient profile through the use of cereal fibers and whole grains All diets will emphasize fruit and vegetable intakes 5-10 servingsd according to current recommendations Participants will be instructed on how to select and follow these diets and will be provided with only the margarine component of the portfolio and Step 2 therapeutic diets The Step 2 therapeutic diet group will be encouraged to follow a diet of whole grain foods brown rice whole wheat breads muffins and breakfast cereals low saturated fat meat and dairy foods with a control margarine The degree to which the portfolio diet can be made effective after routine instruction compared to more intensive instruction is the key issue in this study
Duration of Subject participation and sequence and duration of all trial periods Subject participation will start with the screening visit followed by a week minus 2 visit 4 to 6 weeks later The week minus 2 visit will be followed by week 0 visit Study duration is for 6 months after which participants have the option of continuing for another 6 months
Diets will be self-selected low-fat low-cholesterol NCEP Step 2 diets 7 saturated fats 200 mg dietary cholesterold The test and control margarines will be provided free The oat bran bread will be provided at cost The control diet will encourage a low saturated fat intake 7 by the use of low fat dairy products and egg substitutes Fleischmanns egg beaters Fiber will be increased to 17 g1000 kcal recommending insoluble cereal fiber and whole meal or whole grain flour cereal products which are lipid neutral but conform to current diet guidelines for fiber intake and appear to offer protection from CHD This will ensure equal total fiber intake on the NCEP and Portfolio diet The control margarine 45 gd will have the same fatty acid composition as the test margarine The Portfolio treatment diet will have a similar fatty acid and macronutrient profile to the control treatment diet Low-fat Dairy and egg protein sources will be replaced with soy approximately 45 gd protein Foods will include soy dairy foods milks yogurts cheese and meat analogues made from soy isolate dogs and burgers etc and tofu products The fiber will include at least 15 g viscous fiber daily from oats barley dried beans peas lentils and psyllium cereal Plant sterols 1g1000 kcal diet up to 3gday will be recommended from the test margarine provided which will be consumed up to a quantity of 40 gday A control margarine in the same quantity 25-40 gd will be provided to the participants in the control group Almonds 22g1000 kcal the FDA recommended dose for cholesterol reduction will also be included in the diet The protein and fiber components will be individualized as much as possible to achieve study goals while satisfying individual preferences The portfolio diet will be prescribed at two levels of reinforcement In one portfolio cohort the advice will be general and provided on 2 occasions over a 6 month period For the second portfolio cohort the advice will be much more intensive and provided on 7 occasions total of 8 visits over a 6 month period Participants in the control and less intensive portfolio treatment groups will be seen at weeks 0 12 24 and optionally at 36 and 52 weeks While participants in the intensive portfolio treatment group will be seen at two-weekly intervals for the first month and then monthly for the next five months with a final visit at 6 months and at two monthly intervals thereafter if study is extended to 12 months to ensure the diet plan is acceptable Participants in the intensive advice group will be provided with self-taring scales on which to weigh all food to be consumed
Four Canadian Centers will be involved Vancouver Toronto Manitoba and Quebec City The study will be partially blinded The investigators and technical staff will be blinded but the dietitians and the patients will not be owing to the differences in taste and appearance of the study foods The blinding of physicians at clinic visits is likely to be difficult due to the requirement to ask questions related to diet All patients referred to the four collaborating clinics will be asked whether they would be prepared to modify their diet if that may mean they might lower their blood cholesterol without the use of drugs Those who checked the box for No or only modest dietary change would not be considered further Those who checked the box for significant or radical dietary change would be invited to participate providing they are not at high risk 20 10 yr risk of CHD and were within 30 of their target LDL-C concentrations according to current Canadian Working Group recommendations ie those who would normally be considered for a preliminary test of diet The three groups would be randomized to either a low saturated fat low cholesterol diet Step 2 or a portfolio diet both given as routine clinical advice at week zero with follow up at 3 and 6 months or more intensive advice reinforced intensive portfolio at clinic visits at 2 4 8 12 16 and 20 weeks In the routine portfolio the advice will therefore consist of two half hour sessions with the dietitian 0 and 12 weeks compared to seven for the intensive portfolio 0 2 4 8 12 16 and 20 weeks Prior to starting each diet the nature of the diet will be explained to the participants and instruction on achieving diet goals will be given Follow-up visits will be used to go over the subjects diet record which they have recorded over the previous 7 days and reinforce the original dietary advice The intensive portfolio participants will therefore receive five additional instructional and assessment follow up visits during the course of the study
Trial treatments The portfolio dietary advice will conform to current therapeutic diets appropriate for hypercholesterolemic subjects 7 of energy saturated fat 200 mgd cholesterol plus the combination of viscous fibers soy protein plant sterols and almonds The portfolio diet plan will include foods which contribute 8 g1000 kcal viscous fiber as β-glucan oats barley oat bran breads and soups and psyllium cereal 1 g plant sterol1000 kcal diet in sterol margarine 22 g soy protein1000 kcal soy burgers dogs links other meat analogues milks yogurts and cheese and 22 g almonds1000 kcal The Step 2 therapeutic diet will encourage a similar macronutrient profile through the use of cereal fibers and whole grains All diets will emphasize fruit and vegetable intakes 5-10 servingsd according to current recommendations Participants will be instructed on how to select and follow these diets and will be provided with only the margarine component of the portfolio and Step 2 therapeutic diets The Step 2 therapeutic diet group will be encouraged to follow a diet of whole grain foods brown rice whole wheat breads muffins and breakfast cereals low saturated fat meat and dairy foods with a control margarine The degree to which the portfolio diet can be made effective after routine instruction compared to more intensive instruction is the key issue in this study
Duration of Subject participation and sequence and duration of all trial periods Subject participation will start with the screening visit followed by a week minus 2 visit 4 to 6 weeks later The week minus 2 visit will be followed by week 0 visit Study duration is for 6 months after which participants have the option of continuing for another 6 months
Diets will be self-selected low-fat low-cholesterol NCEP Step 2 diets 7 saturated fats 200 mg dietary cholesterold The test and control margarines will be provided free The oat bran bread will be provided at cost The control diet will encourage a low saturated fat intake 7 by the use of low fat dairy products and egg substitutes Fleischmanns egg beaters Fiber will be increased to 17 g1000 kcal recommending insoluble cereal fiber and whole meal or whole grain flour cereal products which are lipid neutral but conform to current diet guidelines for fiber intake and appear to offer protection from CHD This will ensure equal total fiber intake on the NCEP and Portfolio diet The control margarine 45 gd will have the same fatty acid composition as the test margarine The Portfolio treatment diet will have a similar fatty acid and macronutrient profile to the control treatment diet Low-fat Dairy and egg protein sources will be replaced with soy approximately 45 gd protein Foods will include soy dairy foods milks yogurts cheese and meat analogues made from soy isolate dogs and burgers etc and tofu products The fiber will include at least 15 g viscous fiber daily from oats barley dried beans peas lentils and psyllium cereal Plant sterols 1g1000 kcal diet up to 3gday will be recommended from the test margarine provided which will be consumed up to a quantity of 40 gday A control margarine in the same quantity 25-40 gd will be provided to the participants in the control group Almonds 22g1000 kcal the FDA recommended dose for cholesterol reduction will also be included in the diet The protein and fiber components will be individualized as much as possible to achieve study goals while satisfying individual preferences The portfolio diet will be prescribed at two levels of reinforcement In one portfolio cohort the advice will be general and provided on 2 occasions over a 6 month period For the second portfolio cohort the advice will be much more intensive and provided on 7 occasions total of 8 visits over a 6 month period Participants in the control and less intensive portfolio treatment groups will be seen at weeks 0 12 24 and optionally at 36 and 52 weeks While participants in the intensive portfolio treatment group will be seen at two-weekly intervals for the first month and then monthly for the next five months with a final visit at 6 months and at two monthly intervals thereafter if study is extended to 12 months to ensure the diet plan is acceptable Participants in the intensive advice group will be provided with self-taring scales on which to weigh all food to be consumed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR RCT 68767 | None | None | None |