Effect of Amount and Type of Dietary Carbohydrates on Risk for Cardiovascular Heart Disease and Diabetes

Completed · Not applicable

Conditions studied: Overweight, Cardiovascular Diseases

In brief

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 saturated and transunsaturated fats is known to help lower cardiovascular risk. However, even diets low in these fats can vary widely in other energy providing nutrients, particularly carbohydrates. This study will determine the effects of a higher versus lower carbohydrate diet, each with a high or low glycemic index (GI) composition, on risk factors for CVD and diabetes.

Key facts

Study ID

NCT00608049

Run by

Brigham and Women's Hospital

People needed

189

Starts

2008-02-01

Expected to finish

2011-02-01

Last updated by the study team

2016-07-06

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 Criteria:
• 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 Exclusion Criteria:
• Active or prior CVD (e.g., stroke, heart attack, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, congestive heart failure, symptomatic ischemic heart disease [angina], or arteriosclerotic cardiovascular disease-related therapeutic procedure)
• Diabetes mellitus
• Cancer diagnosis or treatment in the 2 years prior to study entry (note: people with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
• Active inflammatory bowel disease, malabsorption, or major gastrointestinal resection
• Renal insufficiency as determined by a serum creatinine greater than 1.2 mg/dL for women or greater than 1.4 mg/dL for men (these participants can enroll if their estimated glomerular filtration rate is greater than 40 mL/min by either the Cockcroft-Gault equation or the simplified Modification of Diet in Renal Disease equation)
• Emergency room visit or hospital stay for asthma or chronic obstructive pulmonary disease in the 6 months prior to study entry
• Any serious illness not otherwise specified that would interfere with participation
• Laboratory Exclusion Criteria:
• Fasting LDL cholesterol greater than 220 mg/dL and triglycerides greater than 750 mg/dL
• Fasting blood glucose greater than 125 mg/dL
• Serum transaminase greater than 2 times the upper range of normal, or a clinical diagnosis of hepatitis

Where it is running

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
• Harvard T. H. Chan School of Public Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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