Status:
COMPLETED
Postprandial Effects of Walnut Components Versus Whole Walnuts on Cardiovascular Disease (CVD) Risk Reduction
Lead Sponsor:
Penn State University
Collaborating Sponsors:
California Walnut Commission
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00938340
Start Date
August 1 2007
End Date
May 1 2009
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State General Clinical Research Center
University Park, Pennsylvania, United States, 16802