Skip to main content
OpenTrials
Completed

NCT Number: NCT02034383

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Controlled diet for 3 weeks with 0 servings/day of almonds.

Whole Almonds

Other

Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.

Roasted Whole Almonds

Other

Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.

Diced Almonds

Other

Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.

Almond Butter

Other

Controlled diet for 3 weeks with 1.5 servings/day of almond butter.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

David Baer

Fed

Collaborators

  • Almond Board of California

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2014
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.