The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet

February 12, 2015 updated by: David Baer

Macronutrient Absorption From Almonds: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet

The objective of this study is to measure the effect of processing (roasting, slicing, or grinding) on the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The metabolizable energy values, or Atwater general factors, for protein, fat, and carbohydrate are commonly used to calculate the metabolizable energy of a diet. Atwater factors are based on average values of mixed diets and are not exact; thus, using these values could introduce an error in the calculated metabolizable energy of a particular food due to differences in chemical structure and availability. Studies have demonstrated that Atwater general factors overestimate the energy derived from protein and fat, as well as the measured metabolizable energy of mixed diets, particularly those that are high in dietary fiber. Studies are lacking, however, that examine how different processing methods affect the metabolizable energy of a food due to differences in chemical structure and availability.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 25 to 75 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
  • Women who have given birth during the previous 12 months
  • Pregnant women or women who plan to become pregnant or become pregnant during the study
  • Lactating women
  • 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)
  • 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
  • Known (self-reported) allergy or adverse reaction to almonds 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Control
Diet will consist of a controlled diet without almonds for 3 weeks.
Other: Control
Controlled diet for 3 weeks with 0 servings/day of almonds.
EXPERIMENTAL: Whole Almonds
Diet will consist of a controlled diet with whole almonds for 3 weeks.
Other: Whole Almonds
Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.
EXPERIMENTAL: Roasted Whole Almonds
Diet will consist of a controlled diet with roasted whole almonds for 3 weeks.
Other: Roasted Whole Almonds
Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.
EXPERIMENTAL: Diced Almonds
Diet will consist of a controlled diet with diced almonds for 3 weeks.
Other: Diced Almonds
Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.
EXPERIMENTAL: Almond Butter
Diet will consist of a controlled diet with almond butter for 3 weeks.
Other: Almond Butter
Controlled diet for 3 weeks with 1.5 servings/day of almond butter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolizable Energy
Time Frame: End of each 3-week diet period
The metabolizable energy value of almonds and almond butter will be calculated based on the chemical composition and energy content of the consumed diet and excreta.
End of each 3-week diet period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digestibility
Time Frame: End of each 3-week diet period
Fat, protein, and fiber digestibility will be calculated and the effect of almond on nutrient digestibility will be assessed.
End of each 3-week diet period
Almond nutrient metabolism
Time Frame: End of each 3-week diet period
Blood and urine will be analyzed for appearance of almond nutrients and their metabolites.
End of each 3-week diet period
Biomarkers of cardiovascular disease
Time Frame: End of each 3-week diet period
Blood will be analyzed for biomarkers of risk for cardiovascular disease and cancer such as oxidative stress and inflammatory markers.
End of each 3-week diet period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Baer

Collaborators

Almond Board of California

Investigators

  • Principal Investigator: David J. Baer, Ph.D., USDA Beltsville Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • HS45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe