Clinical trial NCT02034383: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
Official title: Macronutrient Absorption From Almonds: The Effect of Processing on the Measured Energy Value of Almonds in the Human Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Focus: Effect of Processing on Energy Value of Almonds
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Almond Board of California
First posted: 2014-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Metabolizable Energy
timeFrame: End of each 3-week diet period
Secondary outcomes:
measure: Digestibility
timeFrame: End of each 3-week diet period
measure: Almond nutrient metabolism
timeFrame: End of each 3-week diet period
measure: Biomarkers of cardiovascular disease
timeFrame: End of each 3-week diet period
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: David J. Baer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.