Clinical Trials Directory

Trials / Completed

CompletedNCT00993278

Effects of the Atkins Diet Versus a Low Fat Diet on Inflammation

Effects of the Atkins Diet Versus a Low Fat Diet on Endothelial Function, Lipid Profiles, and Systemic Markers of Inflammation

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Boston Medical Center · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins) diet versus a low fat (Heart Healthy) diet on cardiovascular health.

Detailed description

The purpose of this study is to compare the effects of a modified Atkins diet (low carbohydrate and low calorie) and a traditional heart healthy diet (low fat and low calorie) on biochemical markers of inflammation and metabolism, anthropometric measurements, vascular studies of endothelial function, adipose tissue composition, and patient compliance and satisfaction over a twelve week period in healthy men and women. Patients will be recruited from the Nutrition and Weight Management Center at Boston Medical Center. Enrolled subjects will be randomly assigned to a reduced calorie diet (either the Atkins diet or a traditional heart healthy diet), and will be counseled by a dietitian and a physician throughout the study period. The patients will have physical exams, labs, vascular studies of endothelial function, and adipose tissue biopsies at baseline and at twelve weeks to assess progress. Participants dietary compliance will be assessed using food journals and 24 hour recall. The Atkins diet appears to have potential to reverse the epidemic of obesity-linked cardiovascular disease (CVD) in the United States. Obesity is in effect an inflammatory state in which adipose (fat) tissue releases adipokines- small, inflammatory proteins. High adipokine levels in the blood lead to an inflammatory response, ultimately damaging the endothelial cells which line the blood vessels and increases the risk of vascular disease. Ultimately the effects of these two different diets will be analyzed to help determine if a low carbohydrate, low calorie diet is more beneficial than a traditional heart healthy diet (low fat, low calorie) at reducing the systemic inflammatory response by using physical exam measures, inflammatory blood markers, vascular ultrasound studies, and adipose tissue biopsies.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLow-Carbohydrate (Modified Atkins) DietLow-Carbohydrate (Modified Atkins) Diet
DIETARY_SUPPLEMENTLow-Fat (Heart Healthy) DietLow-Fat (Heart Healthy) Diet

Timeline

Start date
2008-08-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2009-10-12
Last updated
2015-05-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00993278. Inclusion in this directory is not an endorsement.