Black Walnuts and Health

Study Overview
=================
Brief Summary
-----------------
Walnuts are a nutrient dense food, but most health research is on English walnuts (EW). Black walnuts (BW) contain a different antioxidant and fatty acid profile, and more protein, compared to EW. The purpose of the study was to compare postprandial responses following the consumption of 3 breakfast meals containing either butter (control), BW, or EW.

Detailed Description
-----------------
This study was a randomized, double-blind control trial consisting of 3 study visits for 3 different treatments. The treatments were high-fat breakfast muffins containing either butter (control), black walnuts, or English walnuts. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit. Hypothesis: The walnut-containing meals would mitigate post-meal increases in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Official Title
-----------------
Acute Consumption of Breakfast Meals With Black Walnut, English Walnuts, or no Nuts

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Control
* Other: Black walnut
* Other: English walnut


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men and women Normal-weight (body mass index = 18-24.9kg/m2) Exclusion Criteria: Allergies to test meal ingredients (gluten, eggs, or nuts) Medication/supplement usage Chronic disease Pregnancy or plans to become pregnant Special diets Tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Participants in this group received a traditional muffin with butter as the predominant source of fat. | Other: Control<br>* Participants in this group received a traditional muffin with butter as the predominant source of fat.<br>|
| Experimental: Black walnut<br>Participants in this group received a muffin in which part of the butter was substituted out for black walnuts. | Other: Black walnut<br>* Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.<br>|
| Experimental: English Walnut<br>Participants in this group received a muffin in which part of the butter was substituted out for English walnuts. | Other: English walnut<br>* Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in triglycerides (TG) and glucose responses | TG (mg/dL) and glucose (mg/dL) | Change from baseline to 3 hours postprandially | 
| Change in lipid peroxidation | Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay | Change from baseline to 3 hours postprandially | 
| Change in total antioxidant capacity | Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay. | Change from baseline to 3 hours postprandially | 
| Change in insulin | Insulin (uU/mL) | Change from baseline to 3 hours postprandially | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses | ANGPTL3 (pg/mL) and ANGPTL4 (pg/mL) | Change from baseline to 3 hours postprandially | 
| Change in hunger and satiety responses | Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no hunger, fullness, prospective consumption, and desire to eat, while 100 represents the greatest feeling of these outcomes. | Change from baseline to 3 hours postprandially |