Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051350
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2003-01-09
Brief Title:
OmniHeart Trial Macronutrients and Cardiovascular Risk
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Macronutrients and Cardiovascular Risk
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:
To compare the effects on blood pressure and plasma lipids of three different diets--a carbohydrate-rich diet a protein-rich diet or a diet rich in unsaturated fat
Detailed Description:
BACKGROUND
While there is widespread consensus that the optimal diet to reduce cardiovascular risk should be low in saturated fat the type of macronutrient that should replace saturated fat carbohydrate protein or unsaturated fat is a major unresolved research question with substantial public health implications The study will evaluate these three dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors
DESIGN NARRATIVE
The study design was a randomized three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the DASH diet CARB to two other diets one rich in protein PROTEIN and another rich in unsaturated UNSAT fat predominantly monounsaturated fat The DASH diet has been shown to reduce blood pressure and LDL-cholesterol substantially and is currently recommended by policy makers During a one week run-in all participants were fed samples of the three study diets CARB PROTEIN and UNSAT Using a three period cross-over design participants were then randomly assigned to the CARB PROTEIN or UNSAT diet Each feeding period lasted six weeks a washout period of at least two weeks separated each feeding period Throughout feeding run-in and the three intervention periods participants were fed sufficient calories to maintain their weight Trial participants were 30 years of age or older with systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 90-99 mmHg Primary outcomes variables were blood pressure and the established plasma lipid risk factors LDL-C HDL-C and triglycerides Secondary outcomes include total cholesterol apolipoproteins VLDL-apoB VLDL-apoCIII apolipoprotein B non-HDL cholesterol and lipoproteina
While there is widespread consensus that the optimal diet to reduce cardiovascular risk should be low in saturated fat the type of macronutrient that should replace saturated fat carbohydrate protein or unsaturated fat is a major unresolved research question with substantial public health implications The study will evaluate these three dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors
DESIGN NARRATIVE
The study design was a randomized three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the DASH diet CARB to two other diets one rich in protein PROTEIN and another rich in unsaturated UNSAT fat predominantly monounsaturated fat The DASH diet has been shown to reduce blood pressure and LDL-cholesterol substantially and is currently recommended by policy makers During a one week run-in all participants were fed samples of the three study diets CARB PROTEIN and UNSAT Using a three period cross-over design participants were then randomly assigned to the CARB PROTEIN or UNSAT diet Each feeding period lasted six weeks a washout period of at least two weeks separated each feeding period Throughout feeding run-in and the three intervention periods participants were fed sufficient calories to maintain their weight Trial participants were 30 years of age or older with systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 90-99 mmHg Primary outcomes variables were blood pressure and the established plasma lipid risk factors LDL-C HDL-C and triglycerides Secondary outcomes include total cholesterol apolipoproteins VLDL-apoB VLDL-apoCIII apolipoprotein B non-HDL cholesterol and lipoproteina
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R01HL067098 | NIH | None | httpsreporternihgovquickSearchR01HL067098 |