Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action

Study Overview
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Brief Summary
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The U.S. Department of Agriculture (USDA) wants to learn more about the number of calories in almonds and the mechanisms of the health effects of almonds. Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption and body weight, despite the fact that nuts are an energy dense food. Intervention studies have shown that consumption of nuts has no effect on body weight or an effect that is significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat and energy loss with nut consumption; however studies with almonds are lacking.

Detailed Description
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The objective of this study is to measure the energy value of almonds in the human diet and study molecular mechanisms that may help explain the beneficial health effects of almonds. Epidemiologic studies have demonstrated an inverse or no relationship between nut consumption and body weight, despite the fact that nuts are an energy dense food. Intervention studies have shown that consumption of nuts has no effect on body weight or an effect that is significantly less than predicted. Fecal analyses in studies with peanuts, almonds, and pecans have found increased fecal fat and energy loss with nut consumption; however studies with almonds are lacking. Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of almonds are extremely limited. The aim of this study is to determine the energy value of almonds in the human diet and to probe mechanisms by which almonds impart health benefits. The metabolizable energy value of almond nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of almonds than simply calculating energy value based on Atwater factors. In addition to determining the energy value of almonds, we will evaluate the effects of almond-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by almond consumption.

Official Title
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Energy Value of Macronutrients From Almonds and Mechanisms of Nutrient Action

Conditions
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Healthy

Intervention / Treatment
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* Other: 1.5PD almonds
* Other: 3.0PD almonds
* Other: Base (without almonds)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25 to 65 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 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) Antibiotic use during the intervention or for 3 weeks prior to any intervention period 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 or who plan to initiate a weight loss program during the next 10 months Known (self-reported) allergy or adverse reaction to pistachios 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1.5PD<br>average American diet plus 1.5 oz per day almonds | Other: 1.5PD almonds<br>* average American diet plus 1.5 oz per day almonds<br>|
| Other: Base<br>average American diet without almonds | Other: Base (without almonds)<br>* average American diet without almonds<br>|
| Active Comparator: 3.0PD<br>average American diet plus 3.0 oz per day almonds | Other: 3.0PD almonds<br>* average American diet plus 3.0 oz per day almonds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to measure the energy value of almonds in the human diet |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to study molecular mechanisms that may help explain the beneficial health effects of almonds |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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almond, nuts, energy value, cardiovascular disease, phytonutrient, gene expression, energy value of almonds, energy