Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034383
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : February 13, 2015
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
David Baer, USDA Beltsville Human Nutrition Research Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Focus: Effect of Processing on Energy Value of Almonds Other: Control Other: Whole Almonds Other: Roasted Whole Almonds Other: Diced Almonds Other: Almond Butter Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Macronutrient Absorption From Almonds: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034383


Locations
Layout table for location information
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
David Baer
Almond Board of California
Investigators
Layout table for investigator information
Principal Investigator: David J. Baer, Ph.D. USDA Beltsville Human Nutrition Research Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: David Baer, Research Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02034383    
Other Study ID Numbers: HS45
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015