Clinical Trials Directory

Trials / Completed

CompletedNCT01007188

Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (estimated)
Sponsor
United States Department of Agriculture (USDA) · Federal
Sex
All
Age
25 Years – 65 Years
Healthy volunteers
Accepted

Summary

The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption and body weight, despite the fact that nuts are an energy dense food. Intervention studies have shown that consumption of nuts has no effect on body weight or an effect that is significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat and energy loss with nut consumption; however studies with almonds are lacking.

Detailed description

The objective of this study is to measure the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds. Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption and body weight, despite the fact that nuts are an energy dense food. Intervention studies have shown that consumption of nuts has no effect on body weight or an effect that is significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat and energy loss with nut consumption; however studies with almonds are lacking. Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of almonds are extremely limited. The aim of this study is to determine the energy value of almonds in the human diet and to probe mechanisms by which almonds impart health benefits. The metabolizable energy value of almond nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of almonds than simply calculating energy value based on Atwater factors. In addition to determining the energy value of almonds, we will evaluate the effects of almond-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by almond consumption.

Conditions

Interventions

TypeNameDescription
OTHER1.5PD almondsaverage American diet plus 1.5 oz per day almonds
OTHER3.0PD almondsaverage American diet plus 3.0 oz per day almonds
OTHERBase (without almonds)average American diet without almonds

Timeline

Start date
2010-03-01
Primary completion
2010-05-01
Completion
2010-05-01
First posted
2009-11-03
Last updated
2011-02-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01007188. Inclusion in this directory is not an endorsement.