Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: 1.5PD almonds; Other: Base (without almonds); Other: 3.0PD almonds

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS, Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1.5PD; average American diet plus 1.5 oz per day almonds	Other: 1.5PD almonds; average American diet plus 1.5 oz per day almonds
Other: Base; average American diet without almonds	Other: Base (without almonds); average American diet without almonds
Active Comparator: 3.0PD; average American diet plus 3.0 oz per day almonds	Other: 3.0PD almonds; average American diet plus 3.0 oz per day almonds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to measure the energy value of almonds in the human diet	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
to study molecular mechanisms that may help explain the beneficial health effects of almonds	3 weeks

Collaborators and Investigators

• Sponsor: United States Department of Agriculture (USDA)
• Collaborators: Almond Board of California
• Investigators: Principal Investigator: David J Baer, Ph. D., USDA Beltsville Human Nutrition Research Center

Publications and helpful links

General Publications

• Novotny JA, Gebauer SK, Baer DJ. Discrepancy between the Atwater factor predicted and empirically measured energy values of almonds in human diets. Am J Clin Nutr. 2012 Aug;96(2):296-301. doi: 10.3945/ajcn.112.035782. Epub 2012 Jul 3.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 9, 2011
• Last Update Submitted That Met QC Criteria: February 8, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: cardiovascular disease; almond; gene expression; energy; energy value; nuts; phytonutrient; energy value of almonds
• Other Study ID Numbers: 2009-412