HealthyNCT04849949
Black Walnuts and Health
A study testing Black walnut and English walnut in people with Healthy, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Black walnut and English walnut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 27 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women
- Normal-weight (body mass index = 18-24.9kg/m2)
Who cannot join
- Allergies to test meal ingredients (gluten, eggs, or nuts)
- Medication/supplement usage
- Chronic disease
- Pregnancy or plans to become pregnant
- Special diets
- Tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia - Department of Foods and Nutrition & Department of Food Science and Technology
Athens, Georgia, 30602
About this study
Official title: Acute Consumption of Breakfast Meals With Black Walnut, English Walnuts, or no Nuts
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.
- Conditions
- Healthy
- Being tested
- Control, Black walnut, English walnut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Participants in this group received a traditional muffin with butter as the predominant source of fat.
Black walnutOther
Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.
English walnutOther
Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in this group received a traditional muffin with butter as the predominant source of fat. Receives: Other: Control |
| Black walnut | Experimental | Participants in this group received a muffin in which part of the butter was substituted out for black walnuts. Receives: Other: Black walnut |
| English Walnut | Experimental | Participants in this group received a muffin in which part of the butter was substituted out for English walnuts. Receives: Other: English walnut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in triglycerides (TG) and glucose responses
TG (mg/dL) and glucose (mg/dL)
Measured: Change from baseline to 3 hours postprandially
Change in lipid peroxidation
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay
Measured: 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.
Measured: Change from baseline to 3 hours postprandially
Change in insulin
Insulin (uU/mL)
Measured: Change from baseline to 3 hours postprandially
Secondary outcomes (2)
Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses
ANGPTL3 (pg/mL) and ANGPTL4 (pg/mL)
Measured: 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.
Measured: Change from baseline to 3 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start10 Aug 2017
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
- Investigators
- Chad M Paton, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849949
- Sponsor's protocol ID
- AWD00006706
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Consumption of Breakfast Meals With Black Walnut, English Walnuts, or no Nuts
- ClinicalTrials.gov ID
- NCT04849949
- Acronym / sponsor ID
- AWD00006706
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlParticipants in this group received a traditional muffin with butter as the predominant source of fat. |
| Black walnut | Experimental | Other: Black walnutParticipants in this group received a muffin in which part of the butter was substituted out for black walnuts. |
| English Walnut | Experimental | Other: English walnutParticipants in this group received a muffin in which part of the butter was substituted out for English walnuts. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult men and women
- Normal-weight (body mass index = 18-24.9kg/m2)
Key exclusion criteria (6 listed)
- Allergies to test meal ingredients (gluten, eggs, or nuts)
- Medication/supplement usage
- Chronic disease
- Pregnancy or plans to become pregnant
- Special diets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants in this group received a traditional muffin with butter as the predominant source of fat. | Other | Control |
| Black walnutParticipants in this group received a muffin in which part of the butter was substituted out for black walnuts. | Other | Black walnut |
| English walnutParticipants in this group received a muffin in which part of the butter was substituted out for English walnuts. | Other | English Walnut |
Primary outcome
Change in triglycerides (TG) and glucose responses
Time frame: Change from baseline to 3 hours postprandially
TG (mg/dL) and glucose (mg/dL)
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 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 in insulin
Time frame: Change from baseline to 3 hours postprandially
Insulin (uU/mL)
2 secondary outcomes
Change in angiopoietin-like proteins-3 (ANGPTL3) and -4 (ANGPTL4) responses
Time frame: Change from baseline to 3 hours postprandially
Change in hunger and satiety responses
Time frame: Change from baseline to 3 hours postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Paton, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black walnut and English walnut in people with Healthy, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in triglycerides (TG) and glucose responses (time frame: Change from baseline to 3 hours postprandially). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.