- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849949
Black Walnuts and Health
Acute Consumption of Breakfast Meals With Black Walnut, English Walnuts, or no Nuts
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants in this group received a traditional muffin with butter as the predominant source of fat.
|
Participants in this group received a traditional muffin with butter as the predominant source of fat.
|
Experimental: Black walnut
Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.
|
Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.
|
Experimental: English Walnut
Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.
|
Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in triglycerides (TG) and glucose responses
Time Frame: Change from baseline to 3 hours postprandially
|
TG (mg/dL) and glucose (mg/dL)
|
Change from baseline to 3 hours postprandially
|
Change in lipid peroxidation
Time Frame: Change from baseline to 3 hours postprandially
|
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay
|
Change from baseline to 3 hours postprandially
|
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.
|
Change from baseline to 3 hours postprandially
|
Change in insulin
Time Frame: Change from baseline to 3 hours postprandially
|
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
Time Frame: Change from baseline to 3 hours postprandially
|
ANGPTL3 (pg/mL) and ANGPTL4 (pg/mL)
|
Change from baseline to 3 hours postprandially
|
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.
|
Change from baseline to 3 hours postprandially
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chad M Paton, PhD, University of Georgia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AWD00006706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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