Clinical Trials Directory

Trials / Completed

CompletedNCT01792648

Effects of Almond Intake on Atherogenic Lipoprotein Particles

Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
UCSF Benioff Children's Hospital Oakland · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERStandard reference diet50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
OTHERAlmond supplemented diet50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
OTHERLow carbohydrate reference diet26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat

Timeline

Start date
2013-04-01
Primary completion
2016-02-01
Completion
2016-04-01
First posted
2013-02-15
Last updated
2017-11-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01792648. Inclusion in this directory is not an endorsement.