NCT00993278|CompletedPhase 3
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Sponsor study identifier
interventional
60
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 9, 2009
Actual (reported)October 12, 2009
Actual (reported)January 2011
Actual (reported)January 2011
Actual (reported)Endothelial function via Flow-Mediated Dilation (FMD)
3 months
Systemic inflammatory markers
3 months
Body composition via Dual energy x-ray absorptiometry (DXA)
3 months
Gene expression of adipose tissue
3 months
Low-Carbohydrate (Modified Atkins) Diet
Low-Fat (Heart Healthy) Diet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Boston Medical Center
Boston, Massachusetts, 02118, United States
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.
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.
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.
Caroline M. Apovian, MD
Boston University
60 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2009
First Posted
October 12, 2009
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
May 14, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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