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Completed

NCT Number: NCT04849949

Black Walnuts and Health

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology

Athens, Georgia, 30602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Participants in this group received a traditional muffin with butter as the predominant source of fat.

Black walnut

Other

Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.

English walnut

Other

Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.

Primary outcomes

  1. Change in triglycerides (TG) and glucose responses

    Time frame: Change from baseline to 3 hours postprandially

    TG (mg/dL) and glucose (mg/dL)

  2. Change in lipid peroxidation

    Time frame: Change from baseline to 3 hours postprandially

    Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay

  3. Change in total antioxidant capacity

    Time frame: Change from baseline to 3 hours postprandially

    Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.

  4. Change in insulin

    Time frame: Change from baseline to 3 hours postprandially

    Insulin (uU/mL)

Secondary outcomes

  1. Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses

    Time frame: Change from baseline to 3 hours postprandially

    ANGPTL3 (pg/mL) and ANGPTL4 (pg/mL)

  2. Change in hunger and satiety responses

    Time frame: Change from baseline to 3 hours postprandially

    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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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