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

Not Applicable

Completed

• Conditions: Healthy; Focus: Effect of Processing on Energy Value of Almonds
• Interventions: Other: Diced Almonds; Other: Control; Other: Whole Almonds; Other: Roasted Whole Almonds; Other: Almond Butter

• Registration Number: NCT02034383
• Lead Sponsor: David Baer

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.

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diced Almonds	Diced Almonds	Diet will consist of a controlled diet with diced almonds for 3 weeks.
Control	Control	Diet will consist of a controlled diet without almonds for 3 weeks.
Whole Almonds	Whole Almonds	Diet will consist of a controlled diet with whole almonds for 3 weeks.
Roasted Whole Almonds	Roasted Whole Almonds	Diet will consist of a controlled diet with roasted whole almonds for 3 weeks.
Almond Butter	Almond Butter	Diet will consist of a controlled diet with almond butter for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Metabolizable Energy	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

Name	Time	Method
Digestibility	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.
Biomarkers of cardiovascular disease	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.
Almond nutrient metabolism	End of each 3-week diet period	Blood and urine will be analyzed for appearance of almond nutrients and their metabolites.

Trial Locations

Locations (1)

USDA Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States