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

Primary Purpose

Cardiovascular Health, Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Low-Carbohydrate (Modified Atkins) Diet
Low-Fat (Heart Healthy) Diet
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-Carbohydrate (Modified Atkins) Diet

Low-Fat (Heart Healthy) Diet

Arm Description

Outcomes

Primary Outcome Measures

Endothelial function via Flow-Mediated Dilation (FMD)

Secondary Outcome Measures

Systemic inflammatory markers
Body composition via Dual energy x-ray absorptiometry (DXA)
Gene expression of adipose tissue

Full Information

First Posted
October 9, 2009
Last Updated
May 13, 2015
Sponsor
Boston Medical Center
Collaborators
Robert C. Atkins Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00993278
Brief Title
Effects of the Atkins Diet Versus a Low Fat Diet on Inflammation
Official Title
Effects of the Atkins Diet Versus a Low Fat Diet on Endothelial Function, Lipid Profiles, and Systemic Markers of Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Robert C. Atkins Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Health, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Carbohydrate (Modified Atkins) Diet
Arm Type
Active Comparator
Arm Title
Low-Fat (Heart Healthy) Diet
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-Carbohydrate (Modified Atkins) Diet
Intervention Description
Low-Carbohydrate (Modified Atkins) Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-Fat (Heart Healthy) Diet
Intervention Description
Low-Fat (Heart Healthy) Diet
Primary Outcome Measure Information:
Title
Endothelial function via Flow-Mediated Dilation (FMD)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Systemic inflammatory markers
Time Frame
3 months
Title
Body composition via Dual energy x-ray absorptiometry (DXA)
Time Frame
3 months
Title
Gene expression of adipose tissue
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline M. Apovian, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19389313
Citation
Ogden CL, Carroll MD, McDowell MA, Flegal KM. Obesity among adults in the United States--no statistically significant change since 2003-2004. NCHS Data Brief. 2007 Nov;(1):1-8.
Results Reference
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PubMed Identifier
15181022
Citation
Kershaw EE, Flier JS. Adipose tissue as an endocrine organ. J Clin Endocrinol Metab. 2004 Jun;89(6):2548-56. doi: 10.1210/jc.2004-0395.
Results Reference
background
PubMed Identifier
15148063
Citation
Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med. 2004 May 18;140(10):769-77. doi: 10.7326/0003-4819-140-10-200405180-00006.
Results Reference
background
PubMed Identifier
12679447
Citation
Brehm BJ, Seeley RJ, Daniels SR, D'Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab. 2003 Apr;88(4):1617-23. doi: 10.1210/jc.2002-021480.
Results Reference
background
PubMed Identifier
18195164
Citation
Phillips SA, Jurva JW, Syed AQ, Syed AQ, Kulinski JP, Pleuss J, Hoffmann RG, Gutterman DD. Benefit of low-fat over low-carbohydrate diet on endothelial health in obesity. Hypertension. 2008 Feb;51(2):376-82. doi: 10.1161/HYPERTENSIONAHA.107.101824. Epub 2008 Jan 14.
Results Reference
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Effects of the Atkins Diet Versus a Low Fat Diet on Inflammation

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