The Effects of Walnuts on Antioxidant Capacity and Nutritional Status in Humans
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of this study is to find out if the daily consumption of English walnuts (Juglans regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have a positive effect on antioxidant capacity and nutrient status in a population of healthy adults, aged 50-70 y.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedFebruary 19, 2009
February 1, 2009
10 months
February 20, 2008
February 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutritional status and antioxidant capacity
5 months
Interventions
Subjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged.
Eligibility Criteria
You may qualify if:
- Generally healthy men and postmenopausal women age 50 or over
- BMI 18.5-35 kg/m2
You may not qualify if:
- Cigarette smoking and/or nicotine replacement use
- History or known allergy to nuts of any kind
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Individuals taking estrogen
- Use of cholesterol-lowering medications
- Gastrointestinal disease
- Kidney disease
- Endocrine disease: including diabetes, untreated thyroid disease
- Rheumatoid arthritis
- Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
- Regular use of oral steroids
- Regular daily intake of ≥ 2 alcoholic drinks
- Illicit drug use
- No fish oil supplements (including cod liver oil) for 6 weeks prior to study admission
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- California Walnut Commissioncollaborator
- Tufts Medical Centercollaborator
Study Sites (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (1)
McKay DL, Chen CY, Yeum KJ, Matthan NR, Lichtenstein AH, Blumberg JB. Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized, cross-over pilot study. Nutr J. 2010 May 12;9:21. doi: 10.1186/1475-2891-9-21.
PMID: 20462428DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Diane L McKay, PhD
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
February 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 19, 2009
Record last verified: 2009-02