CClinicalTrials.gg
CompletedNCT04849949Updated Apr 20, 2021

Black Walnuts and Health

An interventional study of Control and Black walnut in Healthy, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by University of Georgia · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Aug 2017, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult men and women
  • Normal-weight (body mass index = 18-24.9kg/m2)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Control

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

    Other: Control

  • Experimental
    Black walnut

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

    Other: Black walnut

  • Experimental
    English Walnut

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

    Other: English walnut

Interventions

  • OtherControl

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

  • OtherBlack walnut

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

  • OtherEnglish walnut

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

06

What researchers measure

Primary outcomes

  1. Change in triglycerides (TG) and glucose responses

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

    Time frame: Change from baseline to 3 hours postprandially

  2. Change in lipid peroxidation

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

    Time frame: Change from baseline to 3 hours postprandially

  3. Change in total antioxidant capacity

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

    Time frame: Change from baseline to 3 hours postprandially

  4. Change in insulin

    Insulin (uU/mL)

    Time frame: Change from baseline to 3 hours postprandially

Secondary outcomes

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

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

    Time frame: Change from baseline to 3 hours postprandially

  2. 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.

    Time frame: Change from baseline to 3 hours postprandially

07

Study locations

1 site
  • University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology
    Athens, Georgia 30602, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04849949
Lead sponsor
University of Georgia
Responsible party
Jamie Cooper, PhD (Professor and Director of UGA Obesity Initiative, University of Georgia) — Principal investigator
First posted
Apr 20, 2021
Start date
Aug 10, 2017
Primary completion
Feb 27, 2018
Completion
Feb 27, 2018
Last update
Apr 20, 2021

Study contacts

Chad M Paton, PhD
principal investigator · University of Georgia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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