Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction

August 16, 2023 updated by: Penn State University

Postprandial Effects of Walnut Components vs Whole Walnuts on Oxidative Stress, Inflammation, Platelet Function, and Endothelial Function in Volunteers With Moderate Hypercholesterolemia

The purpose of this study is to evaluate the acute, postprandial effects and mechanism of action of various walnut components (separated nut skins, de-fatted nut meat, nut oil) versus whole walnuts on oxidative stress, inflammation and measures of platelet and endothelial function in healthy adults with moderately elevated cholesterol levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Walnuts contain high contents of polyunsaturated fatty acids (PUFA), particularly linoleic acid and linolenic acid. The high PUFA content has been suggested to reduce CVD risk through decreasing total and LDL-cholesterol concentrations, and increasing HDL-C concentrations. In addition, walnuts are rich in substances such as ellagic acid (a polyphenol), antioxidants, vitamin E, fiber, essential fatty acids, flavanoids, and phenolic acids. Polyphenolic compounds are believed to have multiple biological effects influencing oxidative stress, platelet function, inflammation, and cancer initiation and propagation. There is interest in identifying foods with these and other favorable compounds to test their efficacy in real world settings to further understand their role in the human diet. Despite positive benefits found in consumption of the walnuts, it is not known which specific component of the walnut (i.e., whole walnut, walnut skin, defatted walnut, or walnut oil) is most beneficial to health. The investigators hypothesize that maximum improvements in oxidative stress, inflammatory markers, platelet and endothelial function will be observed following consumption of the whole nut versus isolated walnut components, thereby leading to a recommendation to consume walnuts. In addition, results from the research proposed will provide new information about the antioxidant, inflammatory, platelet activity and endothelial effects of the different walnut components and the synergistic effects these components have in the postprandial state.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 21 - 60 years
  • Body mass index 25-39 kg/m2
  • LDL cholesterol >110 mg/dL
  • <95 percentile for age and gender for both (based on NHANES data)
  • TG < 350 mg/dL

Exclusion Criteria:

  • High alcohol consumption > 21 units/week (female subjects) or > 28 units/week (male subjects)
  • Intake of vitamin and mineral supplements within the past 3 weeks or unwillingness to discontinue for 3 weeks prior to screening and for entire study.
  • Use of prescription cholesterol-lowering or blood pressure-lowering medications during the study
  • Intake of other putative cholesterol-lowering supplements (excl. psyllium, fish oil capsules, soy lecithin, phytoestrogens)
  • Intake of anti-inflammatory medications (containing aspirin or NSAIDS) on a regular basis or if an acute intake, within 48 hours of a test day
  • Diabetes, liver, kidney, thyroid (unless controlled and stable on replacement medication) or other endocrine disorders from self-reported medical history
  • Treatment with drugs acting on the gut, such as ezetimibe, bile acid-binding resins, orlistat
  • Dietary restrictions such as a medically prescribed diet, or a slimming diet prior to or during the trial
  • Weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination.
  • Blood/plasma donation for reason(s) other than the present study prior to the study (1 month for a male subject or 2 months for a female subject), or during the study
  • Lactation 6 weeks before the start of and during study, pregnant or wishing to become pregnant 3 months before or during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whole walnut
85g whole walnuts, ground, incorporated into inert food carrier
Dietary supplement: Whole walnut
85g whole walnuts, ground, incorporated into inert food carrier
Experimental: Walnut "meat"
Separated, ground walnut de-fatted nut meat incorporated into inert food carrier
Dietary supplement: Walnut "meat"
Separated, ground walnut de-fatted nut meat incorporated into inert food carrier
Experimental: Walnut oil
Walnut oil extracted from nut meat and incorporated into inert food carrier
Dietary supplement: Walnut Oil
Walnut oil extracted from nut meat and incorporated into inert food carrier
Experimental: Walnut skins
Separated, ground walnut skins incorporated into inert food carrier
Dietary supplement: Walnut Skins
Separated, ground walnut skins incorporated into inert food carrier

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Main Effect of Treatment on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments
Time Frame: AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and FRAP was measured at 0, 60, 120, 240, and 360 min. The FRAP assay was used to determine the reducing ability of plasma in a redox-linked colorimetric reaction. Plasma was incubated with the FRAP reagent at room temperature for 1 h and the absorbance at 593 nm was then recorded. Trolox was used as a reference to construct a standard curve to calculate the FRAP value of the samples. The FRAP assay measures lipophilic and hydrophilic antioxidants (total antioxidant capacity), both of which are present in walnuts.
AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
Main Effect of Treatment by Timepoint on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline for each timepoint (60, 120, 240, 360 min)
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) blood sample was collected. Participants then had 15 min to consume 1 of 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and FRAP was measured at 0, 60, 120, 240, and 360 min. The FRAP assay was used to determine the reducing ability of plasma in a redox-linked colorimetric reaction. Plasma was incubated with the FRAP reagent at room temperature for 1 h and the absorbance at 593 nm was then recorded. Trolox was used as a reference to construct a standard curve to calculate the FRAP value of the samples. The FRAP assay measures lipophilic and hydrophilic antioxidants (total antioxidant capacity), both of which are present in walnuts. Several blood samples (n=3) could not be obtained/measured (walnut skin group at 360 min, walnut oil group at 120 min, whole walnut group at 240 min).
Change from baseline for each timepoint (60, 120, 240, 360 min)
Main Effect of Treatment on the Changes in Total Thiol Response to 4 Walnut Treatments
Time Frame: AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and total thiols measured at 0, 60, 120, 240, and 360 min. Total thiols in plasma were determined by the following methods: an aliquot of EDTA plasma was mixed with Tris-EDTA buffer, followed by addition of 10 mmol/L 2,2-dithiobisnitrobenzoic acid and methanol. After incubation at room temperature for 15 min and centrifugation, the absorbance of the supernatant was measured at 412 nm.
AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
Main Effect of Treatment by Timepoint on Total Thiol Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline for each timepoint (60, 120, 240, 360 min)
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and total thiols measured at 0, 60, 120, 240, and 360 min. Total thiols in plasma were determined by the following methods: an aliquot of EDTA plasma was mixed with Tris-EDTA buffer, followed by addition of 10 mmol/L 2,2-dithiobisnitrobenzoic acid and methanol. After incubation at room temperature for 15 min and centrifugation, the absorbance of the supernatant was measured at 412 nm. Several blood samples (n=3) could not be obtained/measured (walnut skin group at 360 min, walnut oil group at 120 min, whole walnut group at 240 min).
Change from baseline for each timepoint (60, 120, 240, 360 min)
Main Effect of Treatment on the Changes in Malondialdehyde (MDA) Response to 4 Walnut Treatments
Time Frame: AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and MDA measured at 0, 60, 120, 240, and 360 min. Plasma MDA was measured by an Agilent 1100 HPLC system with fluorometric detection.
AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
Main Effect of Treatment by Timepoint on Malondialdehyde (MDA) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline for each timepoint (60, 120, 240, 360 min)
On the day of each test, participants arrived at the clinic after a 12-h overnight fast. A baseline (0 min) blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and MDA measured at 0, 60, 120, 240, and 360 min. Plasma MDA was measured by an Agilent 1100 HPLC system with fluorometric detection. Several blood samples (n=2) could not be obtained (walnut oil group at 120 min and whole walnut group at 240 min).
Change from baseline for each timepoint (60, 120, 240, 360 min)
Main Effect of Treatment on the Changes in C-reactive Protein (CRP) Response to 4 Walnut Treatments
Time Frame: AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and CRP measured at 0, 60, 120, 240, and 360 min. Serum CRP was measured by latex-enhanced immunonephelometry.
AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
Main Effect of Treatment by Timepoint on C-reactive Protein (CRP) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline for each timepoint (60, 120, 240, 360 min)
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and CRP measured at 0, 60, 120, 240, and 360 min. Serum CRP was measured by latex-enhanced immunonephelometry. Several blood samples (n=3) could not be obtained/measured (walnut oil/120 min, whole walnut/240 min, and walnut skin/360 min).
Change from baseline for each timepoint (60, 120, 240, 360 min)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Main Effect of Treatment on Reactive Hyperemia Index (RHI) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline at 240 min
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. RHI was calculated as the ratio of the average pulse wave amplitude during hyperemia (60 to 120 s of the post occlusion period) to the average pulse wave amplitude during baseline in the occluded hand divided by the same values in the control hand and then multiplied by a baseline correction factor. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.
Change from baseline at 240 min
Main Effect of Treatment on Framingham Reactive Hyperemia Index (fRHI) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline at 240 min
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. fRHI is an alternative calculation derived from the same raw data (as RHI) and differs in that it uses the period from 90 to 120 s of postocclusion hyperemia, does not incorporate a baseline correction factor, and has a natural log transformation applied to the resulting ratio. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.
Change from baseline at 240 min
Main Effect of Treatment on Heart Rate (HR) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline at 240 min
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. No endothelial function test data available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.
Change from baseline at 240 min
Main Effect of Treatment on Augmentation Index (AI) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline at 240 min
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. AI is a measure of vascular stiffness (pulse wave reflection) that is calculated from the shape of the pulse wave recorded during baseline. No endothelial function test data was available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.
Change from baseline at 240 min
Main Effect of Treatment on Augmentation Index Standardized to a Heart Rate of 75 Beats/Min (AI_75) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline at 240 min
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. At baseline the endothelial function test was performed using pulse amplitude tonometry (PAT) (Itamar Medical). Participants then had 15 min to consume 1 of the 4 walnut test meals. The endothelial function test was performed again at 240 min postmeal. AI is a measure of vascular stiffness (pulse wave reflection) that is calculated from the shape of the pulse wave recorded during baseline. AI can be adjusted to a heart rate of 75 beats/min (AI_75) to correct for the independent effect of heart rate on this measure.No endothelial function test data was available for one participant within the walnut oil group and one within the defatted walnut nutmeat group.
Change from baseline at 240 min
Main Effect of Treatment on the Triglyceride (TG) Changes in Response to 4 Walnut Treatments
Time Frame: AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and TG was measured at 0, 30, 60, 120, 240, and 360 min. TG were determined by standard colorimetric and enzymatic procedures with commercially available kits (Alfa Wassermann).
AUC values were calculated with the trapezoidal rule, using the respective fasting baseline value as the line of reference. Measured at 0 to 360 min (baseline to 360min post meal) for each of the 4 walnut treatments.
Main Effect of Treatment by Timepoint on Triglyceride (TG) Changes in Response to 4 Walnut Treatments
Time Frame: Change from baseline for each timepoint (30, 60, 120, 240, 360 min)
On the day of each test, participants arrived at the General Clinical Research Center after a 12-h overnight fast. A baseline (0 min) fasting blood sample was collected. Participants then had 15 min to consume 1 of the 4 walnut test meals. Blood samples (∼30 mL) were subsequently taken at 30, 60, 120, 240, and 360 min following the meal and TG was measured at 0, 30, 60, 120, 240, and 360 min. TG were determined by standard colorimetric and enzymatic procedures with commercially available kits (Alfa Wassermann). Several blood samples (n=4) could not be obtained/measured [walnut skin group at 360 min (n=1), walnut oil group at 120 min (n=2), whole walnut group at 240 min(n=1)].
Change from baseline for each timepoint (30, 60, 120, 240, 360 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
California Walnut Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKE 102

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