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

NCT ID: NCT02034383

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Healthy; Focus: Effect of Processing on Energy Value of Almonds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Control

Diet will consist of a controlled diet without almonds for 3 weeks.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

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

Whole Almonds

Diet will consist of a controlled diet with whole almonds for 3 weeks.

Group Type: EXPERIMENTAL

Whole Almonds

Intervention Type: OTHER

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

Roasted Whole Almonds

Diet will consist of a controlled diet with roasted whole almonds for 3 weeks.

Group Type: EXPERIMENTAL

Roasted Whole Almonds

Intervention Type: OTHER

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

Diced Almonds

Diet will consist of a controlled diet with diced almonds for 3 weeks.

Group Type: EXPERIMENTAL

Diced Almonds

Intervention Type: OTHER

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

Almond Butter

Diet will consist of a controlled diet with almond butter for 3 weeks.

Group Type: EXPERIMENTAL

Almond Butter

Intervention Type: OTHER

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

Interventions

Control

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

Intervention Type: OTHER

Whole Almonds

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

Intervention Type: OTHER

Roasted Whole Almonds

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

Intervention Type: OTHER

Diced Almonds

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

Intervention Type: OTHER

Almond Butter

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

David Baer

FED

Sponsor Role: lead

Responsible Party

David Baer

Research Physiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David J. Baer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22760558 (View on PubMed)

Other Identifiers

HS45

Identifier Type: -

Identifier Source: org_study_id