OmniHeart Trial: Macronutrients and Cardiovascular Risk

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00051350
First received: January 9, 2003
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Hypertension
Behavioral: Diet therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 2002
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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 lipoprotein(a).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Trial participants were generally healthy adults, aged 30 years and older, with a systolic blood pressure of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg. This range includes individuals with prehypertension (systolic, 120-139 mm Hg or diastolic, 80-89 mm Hg) and stage 1 hypertension (systolic, 140-159 mm Hg or diastolic, 90-99 mm Hg). Prehypertensive individuals are a group at high risk of developing hypertension and CVD, justifying special attempts to lower blood pressure.

Major exclusion criteria were diabetes, active or prior CVD, LDL cholesterol greater than 220 mg/dL (>5.70 mmol/L), fasting triglycerides greater than 750 mg/dL (>8.48 mmol/L), weight more than 350 lb (>159 kg), taking medications that affect blood pressure or blood lipid levels, unwillingness to stop taking vitamin and mineral supplements, and alcoholic beverage intake of more than 14 drinks per week.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051350

Sponsors and Collaborators
Investigators
Investigator: Lawrence Appel Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00051350     History of Changes
Other Study ID Numbers: 1192
Study First Received: January 9, 2003
Last Updated: April 22, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Hypertension
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014