Cardiovascular DiseasesPhase 2NCT04487808
Diet Quality, Pecans, and Cardiometabolic Health
A Phase 2 study testing Pecan and Average American Diet devoid of nuts in people with Cardiovascular Diseases, run by Penn State University.
Trial summary
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Pecan and Average American Diet devoid of nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jul 2022
- Phase
- Phase 2
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥25 and ≤40 kg/m2
- ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
- non-smoking
Who cannot join
- Current tobacco use or use within the previous 6 months
- Diagnosed diabetes or fasting glucose levels > 126 mg/dL at screening
- Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg at screening.
- Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
- History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
- Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
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- Pregnancy, lactation or planning to become pregnant
- Consumption of >14 alcoholic drinks/week
- Intolerance/allergy/sensitivity to foods included in the study menus
About this study
Official title: Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
Read the detailed description
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.
- Conditions
- Cardiovascular Diseases
- Being tested
- Pecan, Average American Diet devoid of nuts
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PecanDrug
Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern
Average American Diet devoid of nutsOther
Diet mimicking usual American intake
| Study group | Role | What they receive |
|---|---|---|
| Average American Diet | Active comparator | Diet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015. Receives: Other: Average American Diet devoid of nuts |
| Average American Diet + Pecans | Active comparator | Diet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans. Receives: Drug: Pecan |
| Healthy Diet + Pecans | Active comparator | High diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans. Receives: Drug: Pecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
Measured by brachial ultrasound and expressed as percent artery dilation
Measured: 4 weeks
Secondary outcomes (11)
LDL-cholesterol concentration
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
HDL-cholesterol concentrations
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
Triglycerides
Assessed from fasting blood draw expressed in mg/dL
Measured: 4 weeks
LDL lipoprotein subclasses
Assessed from fasting blood draw expressed in nmol/L
Measured: 4 weeks
HDL lipoprotein subclasses
Assessed from fasting blood draw expressed in umol/L
Measured: 4 weeks
Peripheral systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical)
Measured: 4 weeks
Central systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Ecel (Atcor Medical).
Measured: 4 weeks
Carotid-femoral pulse wave velocity
A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed in meters/second.
Measured: 4 weeks
Augmentation Index
A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness.
Measured: 4 weeks
Fasting plasma glucose concentration
Fasting blood glucose assessed by blood draw and expressed in mg/dL
Measured: 4 weeks
Serum insulin concentration
Fasting serum insulin levels assessed by blood draw and expressed in micro IU/mL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 May 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: The study did not enroll any subjects. It was never started because of the Covid pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487808
- Sponsor's protocol ID
- Pecan
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2020
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of Including Pecans as a Snack in Dietary Patterns That Vary in Diet Quality: a Randomized, Controlled Feeding, Crossover Study
- ClinicalTrials.gov ID
- NCT04487808
- Acronym / sponsor ID
- Pecan
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not enroll any subjects. It was never started because of the Covid pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 27 Jul 2020 (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.
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.
Detailed description
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Average American Diet | Active comparator | Other: Average American Diet devoid of nutsDiet representative of average American intake in terms of diet quality measured by the Healthy Eating Index-2015. |
| Average American Diet + Pecans | Active comparator | Drug: PecanDiet that approximates average American intake in terms of diet quality measured by the Healthy Eating Index-2015, but includes 2 oz./day of pecans. |
| Healthy Diet + Pecans | Active comparator | Drug: PecanHigh diet quality, measured by Healthy Index-2015 score >95, and includes 2 oz./day of pecans. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥25 and ≤40 kg/m2
- ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
- non-smoking
Key exclusion criteria (9 listed)
- Current tobacco use or use within the previous 6 months
- Diagnosed diabetes or fasting glucose levels > 126 mg/dL at screening
- Systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg at screening.
- Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
- History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
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 |
|---|---|---|
| PecanUnsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern | Drug | Average American Diet + Pecans, Healthy Diet + Pecans |
| Average American Diet devoid of nutsDiet mimicking usual American intake | Other | Average American Diet |
Primary outcome
Flow mediated dilation
Time frame: 4 weeks
Measured by brachial ultrasound and expressed as percent artery dilation
11 secondary outcomes
LDL-cholesterol concentration
Time frame: 4 weeks
HDL-cholesterol concentrations
Time frame: 4 weeks
Triglycerides
Time frame: 4 weeks
LDL lipoprotein subclasses
Time frame: 4 weeks
HDL lipoprotein subclasses
Time frame: 4 weeks
Peripheral systolic and diastolic blood pressure
Time frame: 4 weeks
Central systolic and diastolic blood pressure
Time frame: 4 weeks
Carotid-femoral pulse wave velocity
Time frame: 4 weeks
Augmentation Index
Time frame: 4 weeks
Fasting plasma glucose concentration
Time frame: 4 weeks
Serum insulin concentration
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pecan and Average American Diet devoid of nuts in people with Cardiovascular Diseases, run by Penn State University.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Flow mediated dilation (time frame: 4 weeks). 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 18 Aug 2023.