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

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 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.

Conditions

• Overweight
• Cardiovascular Diseases

Interventions

BEHAVIORAL

High carbohydrate and low glycemic index (GI) diet

The high carbohydrate and low GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.

BEHAVIORAL

Low carbohydrate and low GI diet

The low carbohydrate and low GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of less than 45 on the glucose scale.

BEHAVIORAL

High carbohydrate and high GI diet

The high carbohydrate and high GI diet will require 58% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.

BEHAVIORAL

Low carbohydrate and high GI diet

The low carbohydrate and high GI diet will require 40% of daily calories to be from carbohydrates and will be composed of meals with a GI of greater than 65 on the glucose scale.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Frank M. Sacks, MD · Harvard University

• Lawrence J. Appel, MD · Johns Hopkins Medical Institutions, Baltimore

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• United States

Study Locations