Status:
COMPLETED
Effect of Amount and Type of Dietary Carbohydrates on Risk for Cardiovascular Heart Disease and Diabetes
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Overweight
Cardiovascular Diseases
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
Cardiovascular disease (CVD) and diabetes are health conditions that are strongly influenced by a person's diet. Although the best diet to prevent CVD and diabetes is uncertain, reducing intake of sat...
Detailed Description
A healthy diet can have a remarkable effect on a person's overall health. Research has consistently confirmed the association between diet and serious health problems, including heart disease, diabete...
Eligibility Criteria
Inclusion
- SBP of 120 to 159 mmHg and DBP less than 100 mmHg at study entry (mean over three screening visits) (note: participants with stage 2 hypertension \[SBP greater than 160 mmHg or DBP greater than 100 mmHg\] based on the mean over three screening visits will be excluded, as will participants with a mean SBP greater than 170 mmHg or DBP greater than 105 mmHg at any one visit)
- Overweight or obese, as defined by a body mass index (BMI) greater than 25 kg/m2
- Willing to eat at least one on-site meal per day, 5 days per week, and willing to eat study diets and nothing else during controlled feeding periods
- Medication
Exclusion
- Symptomatic ischemic heart disease (e.g., angina pectoris)
- Regular use of medications that raise or lower BP during the 2 months prior to study entry
- Use of a lipid lowering agent in the 3 weeks prior to study entry
- Unstable dose of hormone replacement therapy, thyroid hormone replacement therapy, and psychotropic medications known to cause weight gain or affect the outcome variables (unstable is defined as a change in dose within 2 months of study entry)
- Use of insulin, oral hypoglycemic agent, lithium, oral corticosteroid, anti-psychotic drugs, weight loss medications, nitrate, or digitalis
- Medical History
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00608049
Start Date
February 1 2008
End Date
February 1 2011
Last Update
July 6 2016
Active Locations (2)
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1
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
2
Harvard T. H. Chan School of Public Health
Boston, Massachusetts, United States, 02215