Black Walnuts and Health

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849949
• Other study ID #: AWD00006706
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: April 2021
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Control
Participants in this group received a traditional muffin with butter as the predominant source of fat.
• Black walnut
Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.
• English walnut
Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.

Locations

Country	Name	City	State
United States	University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in triglycerides (TG) and glucose responses	TG (mg/dL) and glucose (mg/dL)	Change from baseline to 3 hours postprandially
Primary	Change in lipid peroxidation	Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay	Change from baseline to 3 hours postprandially
Primary	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
Primary	Change in insulin	Insulin (uU/mL)	Change from baseline to 3 hours postprandially
Secondary	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
Secondary	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