Tree Nut Consumption to Reduce Abdominal Adiposity

Study Overview
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Brief Summary
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A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal [visceral] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals.

Detailed Description
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A major contributing factor to the rising waist circumference of U.S. young adults is the increase in snacking behavior. Both the frequency of snacking during the day and the percentage of adults who engage in snacking has risen; national data indicates snacking comprises 15-25% of the total daily caloric intake of young and middle-aged adults. Unfortunately, current typical snack items are energy rich, providing high intake of carbohydrates and sugars, as opposed to nuts that are nutrient rich. In prior work with middle-aged adults, the investigators found that consuming tree nuts daily as between-meal snacks for a period of 16 weeks significantly reduced intra-abdominal (visceral) fat and waist circumference, which was associated with altered plasma fatty acid profiles and higher fatty acid oxidation rates. Based on prior findings, the investigators propose to determine whether consuming mixed tree nuts as replacement for typical high carbohydrate snacks reduces abdominal obesity and waist circumference in millennials at risk for MetS. The overarching hypothesis, based on significant preliminary data, is that the quantity and metabolic function of abdominal fat is a key intermediary factor by which greater tree nut consumption reduces ectopic lipid storage (including the accumulation of intra-abdominal [visceral] fat), improves fatty acid and lipoprotein metabolism, reduces systemic inflammation and insulin resistance, and thus, reduces risk for MetS in millennial-generation age individuals. The hypothesis will be tested by determining: 1) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on waist circumference and the quantity of abdominal fat (subcutaneous and visceral fat); 2) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on circulating fatty acid profiles, glucose tolerance and insulin resistance, circulating lipids and lipoproteins, and circulating markers of inflammation; and 3) the effect of consuming mixed tree nuts as daily snacks for 16 weeks on abdominal tissue expression of genes that regulate inflammation, insulin resistance, and cardiometabolic mediators of MetS risk.

Official Title
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Tree Nut Consumption to Reduce Abdominal Adiposity and Risk for Metabolic Syndrome in Millennials

Conditions
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Millenials, Risk for Metabolic Syndrome

Intervention / Treatment
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* Other: High Carbohydrate or Tree Nut Food Snacks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22-36 years BMI 18.5 to 34.9 At least one risk factor for metabolic syndrome based on waist circumference, HDL level or triglyceride level Exclusion Criteria: Tree nut allergy Diagnosed chronic disease Medication for dyslipidemia or hypertension Smoke Weight loss medication Narcotic medication or illicit drug use Pregnancy or lactation or postmenopausal

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 36 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel two-arm study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carb Snacks<br>Will follow study diet based on the Dietary Guidelines and consume study carbohydrate snacks between meals. | Other: High Carbohydrate or Tree Nut Food Snacks<br>* Snack consumption<br>|
| Experimental: Tree Nut Snacks<br>Will follow study diet based on the Dietary Guidelines and consume study tree nut snacks between meals. | Other: High Carbohydrate or Tree Nut Food Snacks<br>* Snack consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Change in waist circumference (in centimeters) | 18 weeks | 
| Visceral Fat | Change in quantity of intra-abdominal fat by CT scan | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Expression in Adipose Tissue | Change in expression of genes involved in regulation of inflammation and insulin resistance | 18 weeks | 
| Inflammation | Change in CRP level (mg/dl) | 18 weeks | 
| Dietary Macronutrient Intake | Change in macronutrient composition of the diet | 18 weeks | 
| Glucose | Change in fasting blood glucose (mg/dl) | 18 weeks | 
| Insulin | Change in serum insulin (mg/dl) | 18 weeks |