Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005532
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2000-05-25
Brief Title:
Dietary Fat Plasma Lipids and Other CHD Risk Factors
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
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:
To assess the extent to which consumption of different sources of hydrogenated fat relative to unhydrogenated oil or butter alters plasma lipoprotein concentrations and measures of lipid metabolism
Detailed Description:
BACKGROUND
Although the consumption of trans-fatty acids or hydrogenated fat has consistently been shown to elevate concentrations of total and LDL cholesterol the effects on HDL-c and Lpa are inconsistent especially when the fats were consumed at moderate levels In addition little is known about the mechanisms by which trans-fatty acids increase total and LDL cholesterol levels or how they may alter the atherogenecity of lipoprotein subfractions The study interventions employ commonly used hydrogenated fats with a wide range of trans-fatty acid levels 15-98 percent The impact will be assessed within the guidelines currently recommended for individuals with moderately elevated plasma levels for which dietary modification is often the first approach to treatment The results of the study may lead to improved public health recommendations concerning trans-fatty acid and hydrogenated fat intake
DESIGN NARRATIVE
Forty subjects 20 male 20 female ages 50 or older with LDL cholesterol concentrations greater than 130 mgdl were fed each of five diets for eight week periods The baseline diet consisted of 36 percent of energy as fat 15 percent saturated 15 percent monosaturated 6 percent polyunsaturated and 160 mg cholesterol1000 kcal The experimental diets contained 30 percent energy as fat 23 of which was derived from each of the following 1 unhydrogenated liquid soybean oil 2 soybean oil margarine in tub form 3 commercial shortening and 4 butter in a randomized double blind cross-over design With the exception of the experimental fat all other foods in the reduced fat diets were identical
The study assessed the impact of consuming diets enriched in hydrogenated and other fats on a plasma lipids and lipoprotein concentrations b apolipoproteins A-1 and B and Lpa concentrations c parameters related to HDL cholesterol particle size composition subfraction distribution HDL2 and HDL3 and HDL with and without A-II d susceptibility of LDL to oxidation e activities of lecithin cholesterol acyltransferase LCAT and cholesterol ester transfer protein and f rates of endogenous cholesterol synthesis
The study was renewed in FY 2000 is to assess the impact of newer approaches to dietary modification with the intent of reducing the risk of developing cardiovascular disease The specific aims of the study are as follow 1 to assess the impact of substituting two classes of fats specifically formulated to substitute for hydrogenated fats ie trans-free margarines and genetically modifiedselectively bred oils on serum lipid levels total VLDL LDL HDL HDL2 and HDL3 cholesterol triglyceride apo A-l and B Lpa immune function and prostaglandin levels and 2 to address unresolved issues related to plant sterols including the relative efficacy of currently available preparations impact of the fat and cholesterol content of the diet and effect of dosing frequency on serum lipids endogenous cholesterol synthesis cholesterol absorption and fat soluble vitamin levels Study subjects are older 50-75 y hypercholesterolemic female and male subjects LDL cholesterol 130-160 mgdl Each 5-week diet phase will be scheduled in randomized order all food and drink will be provided In Part 1 Study 1 subjects will consume each of 3 diets 30 percent fat 23 experimental fat 80 mg cholesterol1000 kcal with the following experimental fats conventional soft margarine trans-free margarine interesterified palm kernel liquid oil trans-free margarine fully hydrogenated soybean oil liquid oil In Part 1 Study 2 subjects will consume each of 6 diets as above with the following experimental fats hydrogenated soybean shortening high oleic sunflower high oleic soybean high oleic canola low saturated soybean and low linolenic soybean oils In Part 2 Study 1 subjects will consume each of 4 diets 38 percent fat 15 percent SFA 14 percent MUFA 6 percent PUFA 200 mg cholesterol1000 kcal baseline and the following sitostanol ester sitostenol ester and genetically modified high sterol oil In Part 2 Study 2 subjects will consume each of 4 plant sterol enriched diets high fat as above with high 200 mg or low 80 mg cholesterol1000 kcal and low fat 20 percent fat 5 percent SFA 75 percent MUFA 75 percent PUFA with high or low cholesterol In Part 2 Study 3 the effect of dosing regime will be assessed using the most efficacious plant sterol as identified in Study 1 and diet as in Study 2 single bolus or in 3 divided doses
Although the consumption of trans-fatty acids or hydrogenated fat has consistently been shown to elevate concentrations of total and LDL cholesterol the effects on HDL-c and Lpa are inconsistent especially when the fats were consumed at moderate levels In addition little is known about the mechanisms by which trans-fatty acids increase total and LDL cholesterol levels or how they may alter the atherogenecity of lipoprotein subfractions The study interventions employ commonly used hydrogenated fats with a wide range of trans-fatty acid levels 15-98 percent The impact will be assessed within the guidelines currently recommended for individuals with moderately elevated plasma levels for which dietary modification is often the first approach to treatment The results of the study may lead to improved public health recommendations concerning trans-fatty acid and hydrogenated fat intake
DESIGN NARRATIVE
Forty subjects 20 male 20 female ages 50 or older with LDL cholesterol concentrations greater than 130 mgdl were fed each of five diets for eight week periods The baseline diet consisted of 36 percent of energy as fat 15 percent saturated 15 percent monosaturated 6 percent polyunsaturated and 160 mg cholesterol1000 kcal The experimental diets contained 30 percent energy as fat 23 of which was derived from each of the following 1 unhydrogenated liquid soybean oil 2 soybean oil margarine in tub form 3 commercial shortening and 4 butter in a randomized double blind cross-over design With the exception of the experimental fat all other foods in the reduced fat diets were identical
The study assessed the impact of consuming diets enriched in hydrogenated and other fats on a plasma lipids and lipoprotein concentrations b apolipoproteins A-1 and B and Lpa concentrations c parameters related to HDL cholesterol particle size composition subfraction distribution HDL2 and HDL3 and HDL with and without A-II d susceptibility of LDL to oxidation e activities of lecithin cholesterol acyltransferase LCAT and cholesterol ester transfer protein and f rates of endogenous cholesterol synthesis
The study was renewed in FY 2000 is to assess the impact of newer approaches to dietary modification with the intent of reducing the risk of developing cardiovascular disease The specific aims of the study are as follow 1 to assess the impact of substituting two classes of fats specifically formulated to substitute for hydrogenated fats ie trans-free margarines and genetically modifiedselectively bred oils on serum lipid levels total VLDL LDL HDL HDL2 and HDL3 cholesterol triglyceride apo A-l and B Lpa immune function and prostaglandin levels and 2 to address unresolved issues related to plant sterols including the relative efficacy of currently available preparations impact of the fat and cholesterol content of the diet and effect of dosing frequency on serum lipids endogenous cholesterol synthesis cholesterol absorption and fat soluble vitamin levels Study subjects are older 50-75 y hypercholesterolemic female and male subjects LDL cholesterol 130-160 mgdl Each 5-week diet phase will be scheduled in randomized order all food and drink will be provided In Part 1 Study 1 subjects will consume each of 3 diets 30 percent fat 23 experimental fat 80 mg cholesterol1000 kcal with the following experimental fats conventional soft margarine trans-free margarine interesterified palm kernel liquid oil trans-free margarine fully hydrogenated soybean oil liquid oil In Part 1 Study 2 subjects will consume each of 6 diets as above with the following experimental fats hydrogenated soybean shortening high oleic sunflower high oleic soybean high oleic canola low saturated soybean and low linolenic soybean oils In Part 2 Study 1 subjects will consume each of 4 diets 38 percent fat 15 percent SFA 14 percent MUFA 6 percent PUFA 200 mg cholesterol1000 kcal baseline and the following sitostanol ester sitostenol ester and genetically modified high sterol oil In Part 2 Study 2 subjects will consume each of 4 plant sterol enriched diets high fat as above with high 200 mg or low 80 mg cholesterol1000 kcal and low fat 20 percent fat 5 percent SFA 75 percent MUFA 75 percent PUFA with high or low cholesterol In Part 2 Study 3 the effect of dosing regime will be assessed using the most efficacious plant sterol as identified in Study 1 and diet as in Study 2 single bolus or in 3 divided doses
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL054727 | NIH | None | httpsreporternihgovquickSearchR01HL054727 |