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

This study has been completed.
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00993278
First received: October 9, 2009
Last updated: January 24, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Cardiovascular Health
Obesity
Dietary Supplement: Low-Carbohydrate (Modified Atkins) Diet
Dietary Supplement: Low-Fat (Heart Healthy) Diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of the Atkins Diet Versus a Low Fat Diet on Endothelial Function, Lipid Profiles, and Systemic Markers of Inflammation

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Endothelial function via Flow-Mediated Dilation (FMD) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systemic inflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Body composition via Dual energy x-ray absorptiometry (DXA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Gene expression of adipose tissue [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-Carbohydrate (Modified Atkins) Diet Dietary Supplement: Low-Carbohydrate (Modified Atkins) Diet
Low-Carbohydrate (Modified Atkins) Diet
Active Comparator: Low-Fat (Heart Healthy) Diet Dietary Supplement: Low-Fat (Heart Healthy) Diet
Low-Fat (Heart Healthy) Diet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • BMI greater than or equal to 30

Exclusion Criteria:

  • Currently pregnant or lactating
  • Type 2 diabetes
  • Use of oral anti-diabetes medications (with exception of Metformin for control of PCOS)
  • Presence of known peripheral arterial or cardiovascular disease
  • Change in body weight (greater or equal to 3% within the past 3 months)
  • Recent use (within the four weeks prior to screening) of weight loss medications including but not limited to phentermine, sibutramine, orlistat, or over the counter weight loss products
  • History of an eating disorder or significant disordered eating behaviors such as binging/purging, abuse of laxatives or diuretics
  • History of established renal or hepatic disease
  • History of prior bariatric surgery
  • Subjects who report routine tobacco use
  • Subjects on Angiotensin receptor blockers (medications such as but not limited too Adicant, Losartan, Avapro, Diovan, Micardis, Teveten, Candesarten/thiazide, Ibesarten/thiazide, Valsartan/thiazide, Losarten/thiazide, Telmisarten/thiazide, Teveten/thiazide
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00993278

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Robert C. Atkins Foundation
Investigators
Principal Investigator: Caroline M. Apovian, MD Boston University
  More Information

Additional Information:
Publications:
Responsible Party: Caroline M. Apovian, MD, FACP, FACN, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00993278     History of Changes
Other Study ID Numbers: H-27361
Study First Received: October 9, 2009
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014