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| Name | Class |
|---|---|
| Robert C. Atkins Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Carbohydrate (Modified Atkins) Diet | Active Comparator |
| |
| Low-Fat (Heart Healthy) Diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Carbohydrate (Modified Atkins) Diet | Dietary Supplement | Low-Carbohydrate (Modified Atkins) Diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function via Flow-Mediated Dilation (FMD) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic inflammatory markers | 3 months | |
| Body composition via Dual energy x-ray absorptiometry (DXA) | 3 months | |
| Gene expression of adipose tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline M. Apovian, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19389313 | Background | 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. | |
| 15181022 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004035 | Diet Therapy |
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| Low-Fat (Heart Healthy) Diet | Dietary Supplement | Low-Fat (Heart Healthy) Diet |
|
| 3 months |
| 15148063 | Background | 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. |
| 12679447 | Background | 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. |
| 18195164 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |