Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction
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| ClinicalTrials.gov Identifier: NCT00938340 |
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Recruitment Status :
Completed
First Posted : July 13, 2009
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
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Sponsor:
Penn State University
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
| Condition |
Cardiovascular Disease |
| Interventions |
Dietary Supplement: Walnut "meat" Dietary Supplement: Walnut Oil Dietary Supplement: Walnut Skins Dietary Supplement: Whole walnut |
| Enrollment | 20 |
Participant Flow
| Recruitment Details | Participants were recruited through advertisements in the local newspaper and university e-mails from April 2008 to October 2008. |
| Pre-assignment Details | Of the individuals (n=246) who were contacted and screened with a semi-structured telephone interview, 50 qualified and were scheduled for a screening visit at the Penn State General Clinical Research Center. After written informed consent was obtained, a fasting blood sample was drawn. Eligible participants (n=20) were randomized to the study. |
| Arm/Group Title | Walnut Intervention |
|---|---|
 Arm/Group Description |
Four different treatments were provided to each participant in a randomized-crossover fashion: ground whole walnuts (85 g), walnut skins (5.6 g) derived from whole walnuts, walnut oil (51 g) extracted from whole walnuts, or skinless, defatted walnut nutmeat (34 g) from whole walnuts. Each treatment was incorporated into an inert food carrier. |
| Period Title: Overall Study | |
| Started | 20 |
| Received Whole Walnut Intervention | 16 |
| Received Walnut Nutmeat Intervention | 19 |
| Received Walnut Skins Intervention | 15 |
| Received Walnut Oil Intervention | 15 |
| Completed | 15 |
| Not Completed | 5 |
| Reason Not Completed | |
| Withdrawal by Subject | 3 |
| Protocol Violation | 1 |
| Adverse Event | 1 |
Baseline Characteristics
| Arm/Group Title | All Completed Participants (n=15) | |
|---|---|---|
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Arm/Group Description |
Whole walnut (85 g) Walnut skins (5.6 g) Walnut oil (51 g) Defatted walnut nutmeat (34 g) | |
| Overall Number of Baseline Participants | 15 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 15 participants | |
| 49 (9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 15 participants | |
| Female |
9 60.0%
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| Male |
6 40.0%
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Body mass index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 15 participants | |
| 29 (4) | ||
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Systolic blood pressure
Mean (Standard Deviation) Unit of measure: Mm Hg |
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| Number Analyzed | 15 participants | |
| 119 (10) | ||
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Diastolic blood pressure
Mean (Standard Deviation) Unit of measure: Mm Hg |
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| Number Analyzed | 15 participants | |
| 76 (9) | ||
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Total cholesterol
Mean (Standard Deviation) Unit of measure: mmol/L |
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| Number Analyzed | 15 participants | |
| 5.0 (0.7) | ||
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LDL-cholesterol
Mean (Standard Deviation) Unit of measure: mmol/L |
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| Number Analyzed | 15 participants | |
| 3.4 (0.6) | ||
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HDL-cholesterol
Mean (Standard Deviation) Unit of measure: mmol/L |
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| Number Analyzed | 15 participants | |
| 1.1 (0.3) | ||
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Triglycerides
Mean (Standard Deviation) Unit of measure: mmol/L |
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| Number Analyzed | 15 participants | |
| 1.2 (0.5) | ||
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Ferric reducing antioxidant potential (FRAP)
Mean (Standard Deviation) Unit of measure: Umol TE/L |
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| Number Analyzed | 15 participants | |
| 1148 (195) | ||
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Total thiols
Mean (Standard Deviation) Unit of measure: mmol/L |
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| Number Analyzed | 15 participants | |
| 0.40 (0.11) | ||
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Malondialdehyde (MDA)
Mean (Standard Deviation) Unit of measure: umol/L |
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| Number Analyzed | 15 participants | |
| 0.75 (0.32) | ||
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Reactive hyperemia index (RHI)
[1] Mean (Standard Deviation) Unit of measure: Ratio |
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| Number Analyzed | 15 participants | |
| 2.0 (0.6) | ||
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[1]
Measure Description: 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.
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Framingham reactive hyperemia index (fRHI)
[1] Mean (Standard Deviation) Unit of measure: Ln(ratio) |
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| Number Analyzed | 15 participants | |
| 0.43 (0.39) | ||
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[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Penny Kris-Etherton |
| Organization: | Penn State University |
| EMail: | pmk3@psu.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Penny Kris-Etherton, Penn State University |
| ClinicalTrials.gov Identifier: | NCT00938340 |
| Other Study ID Numbers: |
PKE 102 |
| First Submitted: | June 18, 2009 |
| First Posted: | July 13, 2009 |
| Results First Submitted: | November 14, 2013 |
| Results First Posted: | October 29, 2018 |
| Last Update Posted: | October 29, 2018 |