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Saturated Fat and Protein Effects on Atherogenic Dyslipidemia
Sponsor study identifier
Secondary identifiers
interventional
113
1 country
1
Study Start
January 2012
Actual (reported)Primary Completion
November 2016
Actual (reported)Study Completion
May 2017
Actual (reported)There is growing epidemiological evidence that consumption of red meat is associated with greater incidence of Cardiovascular Disease (CVD) than either white meat or non-meat foods. Research from our group has shown that a high saturated fat (SF) diet with a moderate red meat content selectively increases intermediate density lipoproteins (IDL) and larger low density lipoproteins (LDLs), which are more weakly associated with CVD risk than smaller LDLs. In contrast, the investigators have found that with a similar intake of SF, high beef consumption results in a preferential increase in small and medium LDL particles that are strongly related to CVD. To date, no studies have directly compared the lipoprotein effects of red meat with that of other food sources of protein in the context of both high and low saturated fat intake. The overall objective of this project is to test the hypothesis that the effects of SF on lipoprotein markers of CVD risk are influenced by sources of dietary protein. The investigators hypothesize that adverse effects of SF on plasma levels of LDL-cholesterol (C), apolipoprotein B (apo B), and atherogenic LDL particles are greater in a diet with a high content of red meat than in diets in which the major proteins are from white meat (poultry) or non-meat sources. The investigators propose a clinical trial in which 180 healthy men and women will be randomized to high SF or low SF diet groups, and within each group, consume diets with equivalent amounts of protein from red meat, white meat, and non-meat sources for 4 wks each in random order. Specifically, the investigators will test whether: (1) With high SF, the red meat diet, compared to the other protein sources, will result in higher levels of LDL-C, apoB, small and medium LDL, and total/high density lipoprotein (HDL)C; (2) With low SF, dietary protein source will not be related to any of these measurements; (3) With both the white meat and non-meat protein diets, increased LDL-C with high vs. low SF will be due primarily to increases in large LDL, whereas with red meat the additional increase in small and medium LDL will result in greater increases in plasma apoB and total LDL particle number. Aim 4 will test hypotheses that increases in small and medium LDL with high SF plus red meat are related to increased activity of hepatic lipase, a key determinant of small LDL production, and that increases in large LDL induced by high SF are related to suppression of LDL receptors. The investigators will also assess the effects of protein source and saturated fat content on markers of insulin resistance, inflammation and endothelial function.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2017
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 31, 2011
Actual (reported)September 2, 2011
Actual (reported)January 2012
Actual (reported)November 2016
Actual (reported)May 2017
Actual (reported)Change from baseline in LDL-Cholesterol
6 weeks, 12 weeks, 18 weeks
Change from baseline in ApoB
6 weeks, 12 weeks, 18 weeks
Change from baseline in Small + Medium Sized LDL
6 weeks, 12 weeks, 18 weeks
Change from baseline in Total Cholesterol/HDL Cholesterol ratio
6 weeks, 12 weeks, 18 weeks
4 weeks of a high saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (15% kcal from saturated fat))
4 weeks of a high saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (15% kcal from saturated fat))
Cholesterol Research Center, Children's Hospital Research Institute
Berkeley, California, 94705, United States
Gadgil MD, Stroebel BM, King SM, Bergeron N, Chiu S, Krauss RM. Effects of Protein Source and Amount of Saturated Fat on Insulin Sensitivity, Insulin Secretion, and Disposition Index in Healthy Individuals. J Nutr. 2026 May;156(5):101458. doi: 10.1016/j.tjnut.2026.101458. Epub 2026 Mar 2.
Ferrell M, Bazeley P, Wang Z, Levison BS, Li XS, Jia X, Krauss RM, Knight R, Lusis AJ, Garcia-Garcia JC, Hazen SL, Tang WHW. Fecal Microbiome Composition Does Not Predict Diet-Induced TMAO Production in Healthy Adults. J Am Heart Assoc. 2021 Nov 2;10(21):e021934. doi: 10.1161/JAHA.121.021934. Epub 2021 Oct 29.
Ronald M Krauss, MD
UCSF Benioff Children's Hospital Oakland
Nathalie Bergeron, PhD
Children's Hospital Oakland Research Institiute
113 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2011
First Posted
September 2, 2011
Study Start
January 2012
Actual (reported)Change from baseline in HDL-Cholesterol
6 weeks, 12 weeks, 18 weeks
Change from baseline in non-HDLC
6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAI
6 weeks, 12 weeks, 18 weeks
Change from baseline in apoAII
6 weeks, 12 weeks, 18 weeks
Change from baseline in HDL2 Cholesterol
6 weeks, 12 weeks, 18 weeks
4 weeks of a high saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (15% kcal from saturated fat))
4 weeks of a low saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (7% kcal from saturated fat))
4 weeks of a low saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (7% kcal from saturated fat))
4 weeks of a low saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (7% kcal from saturated fat))
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Bergeron N, Chiu S, Williams PT, M King S, Krauss RM. Effects of red meat, white meat, and nonmeat protein sources on atherogenic lipoprotein measures in the context of low compared with high saturated fat intake: a randomized controlled trial. Am J Clin Nutr. 2019 Jul 1;110(1):24-33. doi: 10.1093/ajcn/nqz035.
Primary Completion
November 2016
Actual (reported)Study Completion
May 2017
Actual (reported)Last Updated
November 24, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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