Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action

United States Department of Agriculture (USDA)

Status

Completed

Conditions

Healthy

Treatments

Other: 1.5PD almonds

Other: Base (without almonds)

Other: 3.0PD almonds

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01007188

2009-412

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 25 to 65 years at beginning of study
BMI between 20 and 38 kg/m2
Fasting glucose < 126 mg/dl
Blood pressure < 160/100 (controlled with certain medications)
Fasting total blood cholesterol < 280 mg/dl
Fasting triglycerides < 300 mg/dl

Exclusion criteria

Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
History of bariatric or certain other surgeries related to weight control
Smokers or other tobacco users (during 6 months prior to the start of the study)
Antibiotic use during the intervention or for 3 weeks prior to any intervention period
History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
Known (self-reported) allergy or adverse reaction to pistachios or other nuts
Unable or unwilling to give informed consent or communicate with study staff
Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol