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Sponsor study identifier
interventional
24
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches. Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses. The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended. This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference). We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2012
Actual (reported)February 15, 2013
Actual (reported)April 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 2016
Actual (reported)April 2016
Actual (reported)Change in Total and LDL cholesterol
Change in total and LDL cholesterol between each of the 3 test diets
3 weeks, 8 weeks, 13 weeks
Change in small and medium LDL particles
Change in small and medium LDL particles between each of the 3 test diets
3 weeks, 8 weeks, and 13 weeks
Change in apolipoprotein B
Change in apolipoprotein B between each of the 3 test diets
3 weeks, 8 week, 13 weeks
Change in total/HDL-cholesterol ratio
3 weeks, 8 weeks, 13 weeks
Change in LDL peak particle diameter
3 weeks, 8 week, 13 weeks
Change in plasma triglycerides
3 weeks, 8 weeks, 13 weeks
Change in HDL-cholesterol
3 weeks, 8 weeks, 13 weeks
Change in large HDL particles
3 weeks, 8 weeks, 13 weeks
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
Cholesterol Research Center
Berkeley, California, 94705, United States
Williams PT, Bergeron N, Chiu S, Krauss RM. A randomized, controlled trial on the effects of almonds on lipoprotein response to a higher carbohydrate, lower fat diet in men and women with abdominal adiposity. Lipids Health Dis. 2019 Apr 3;18(1):83. doi: 10.1186/s12944-019-1025-4.
Ronald M Krauss, MD
UCSF Benioff Children's Hospital Oakland
24 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2012
First Posted
February 15, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
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Primary Completion
February 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
November 6, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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