N/A
Completed N=20
Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction
Source: ClinicalTrials.gov NCT00938340 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Main Effect of Treatment on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments — -26; 28; 9; -135 umol Trolox equivalents (TE)*min/L — p=<0.01
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Effect of Treatment on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments |
-26; 28; 9; -135 | <0.01 sig |
| PRIMARY Main Effect of Treatment by Timepoint on the Ferric Reducing Antioxidant Potential (FRAP) Changes in Response to 4 Walnut Treatments |
69; -34; -65; -75; -4; 10 | 0.15 |
| PRIMARY Main Effect of Treatment on the Changes in Total Thiol Response to 4 Walnut Treatments |
0.024; 0.010; 0.011; 0.026 | 0.79 |
| PRIMARY Main Effect of Treatment by Timepoint on Total Thiol Changes in Response to 4 Walnut Treatments |
0.051; 0.035; 0.001; 0.010; 0.018; -0.004 | 0.53 |
| PRIMARY Main Effect of Treatment on the Changes in Malondialdehyde (MDA) Response to 4 Walnut Treatments |
-0.015; 0.004; 0.041; -0.001 | >0.05 |
| PRIMARY Main Effect of Treatment by Timepoint on Malondialdehyde (MDA) Changes in Response to 4 Walnut Treatments |
-0.081; -0.018; -0.022; 0.063; -0.054; 0.047 | >0.05 |
| PRIMARY Main Effect of Treatment on the Changes in C-reactive Protein (CRP) Response to 4 Walnut Treatments |
0.10; 0.01; 0.20; 0.12 | >0.05 |
| PRIMARY Main Effect of Treatment by Timepoint on C-reactive Protein (CRP) Changes in Response to 4 Walnut Treatments |
0.12; 0.08; 0.06; 0.16; 0.04; 0.03 | >0.05 |
| SECONDARY Main Effect of Treatment on Reactive Hyperemia Index (RHI) Changes in Response to 4 Walnut Treatments |
-0.19; -0.26; 0.07; -0.09 | 0.012 sig |
| SECONDARY Main Effect of Treatment on Framingham Reactive Hyperemia Index (fRHI) Changes in Response to 4 Walnut Treatments |
-0.14; -0.14; 0.09; -0.02 | 0.010 sig |
| SECONDARY Main Effect of Treatment on Heart Rate (HR) Changes in Response to 4 Walnut Treatments |
3.9; 0.2; 4.4; 1.9 | 0.007 sig |
| SECONDARY Main Effect of Treatment on Augmentation Index (AI) Changes in Response to 4 Walnut Treatments |
-6.6; -1.4; -2.6; -4.0 | 0.44 |
| SECONDARY 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 |
-4.0; -1.2; -0.1; -2.9 | 0.62 |
| SECONDARY Main Effect of Treatment on the Triglyceride (TG) Changes in Response to 4 Walnut Treatments |
0.24; 0.05; 0.24; 0.09 | 0.011 sig |
| SECONDARY Main Effect of Treatment by Timepoint on Triglyceride (TG) Changes in Response to 4 Walnut Treatments |
0.04; 0.13; 0.32; 0.47; 0.24; 0.05 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Age 21 - 60 years
- Body mass index 25-39 kg/m2
- LDL cholesterol >110 mg/dL
- 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
Data sourced from ClinicalTrials.gov (NCT00938340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.