Walnuts and Healthy Aging
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Ocular |
| Therapuetic Areas: | Ophthalmology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 63 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | December 2016 |
Effect of Daily Ingestion of Walnuts for 2 Years on Age-related Cognitive Decline and Macular Degeneration in Healthy Elderly Subjects: A Randomized, Single Blind, Dual Center, Controlled Trial
This will be a systematic investigation of the role of walnuts in preventing or slowing age
related cognitive decline and age related macular degeneration. 700 subjects will be
recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in
Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the
control group for a 2 year intervention. Baseline and annual data will be collected and
analyzed.
related cognitive decline and age related macular degeneration. 700 subjects will be
recruited between 2 sites, Loma Linda University in California, USA and Hospital Clinic in
Barcelona, Spain. Participants will be randomly assigned to either the walnut group or the
control group for a 2 year intervention. Baseline and annual data will be collected and
analyzed.
Epidemiological studies suggest that nutrients such as n-3 polyunsaturated fatty acid,
antioxidants and B-vitamins may protect against age related cognitive decline. Small human
studies have shown beneficial effects of polyphenol rich foods on cognition and age related
macular degeneration. Walnuts are a rich source of n-3 polyunsaturated fatty acid,
alpha-linolenic acid, antioxidants, polyphenols and other bioactive compounds. A 2-year
intervention will be conducted with healthy, elderly subjects to investigate the role of
walnuts in preventing or slowing age related cognitive decline and age related macular
degeneration.
350 subjects, age 63 to 79 years, will be recruited at each of 2 sites, Loma Linda
University in California and Hospital Clinic in Barcelona. Participants will be randomly
assigned to one of two groups: walnut group (habitual diet with 1 or 1.5 oz/d walnut
supplement) or control group (habitual diet only). At baseline and yearly, cardiometabolic
risk factors, red blood cell membrane fatty acids, urinary polyphenols and biomarkers of
inflammation and oxidation will be measured. Eye exam, blood pressure and cognitive function
tests will be measured at the beginning and end of 2 years. At the Barcelona site only,
participants will be given a brain MRI and carotid ultrasound.
Descriptive results will be reported as mean plus/minus standard deviation. Primary analysis
will be carried out on the basis of groups as randomly assigned. Results will be presented
as appropriate effect sizes with a measure of precision (95% CI). Analysis of covariates
gender, age, educational status will be conducted.
antioxidants and B-vitamins may protect against age related cognitive decline. Small human
studies have shown beneficial effects of polyphenol rich foods on cognition and age related
macular degeneration. Walnuts are a rich source of n-3 polyunsaturated fatty acid,
alpha-linolenic acid, antioxidants, polyphenols and other bioactive compounds. A 2-year
intervention will be conducted with healthy, elderly subjects to investigate the role of
walnuts in preventing or slowing age related cognitive decline and age related macular
degeneration.
350 subjects, age 63 to 79 years, will be recruited at each of 2 sites, Loma Linda
University in California and Hospital Clinic in Barcelona. Participants will be randomly
assigned to one of two groups: walnut group (habitual diet with 1 or 1.5 oz/d walnut
supplement) or control group (habitual diet only). At baseline and yearly, cardiometabolic
risk factors, red blood cell membrane fatty acids, urinary polyphenols and biomarkers of
inflammation and oxidation will be measured. Eye exam, blood pressure and cognitive function
tests will be measured at the beginning and end of 2 years. At the Barcelona site only,
participants will be given a brain MRI and carotid ultrasound.
Descriptive results will be reported as mean plus/minus standard deviation. Primary analysis
will be carried out on the basis of groups as randomly assigned. Results will be presented
as appropriate effect sizes with a measure of precision (95% CI). Analysis of covariates
gender, age, educational status will be conducted.
Inclusion Criteria:
- 63 to 79 years old
- healthy men and women
- able to attend clinic at a study sites
Exclusion Criteria:
- illiteracy or inability to understand the protocol
- unable to undergo neurophysiological tests
- morbid obesity (BMI greater than or equal to ≥ 40 kg/m2)
- uncontrolled diabetes (HbA1c>85)
- uncontrolled hypertension
- prior cerebrovascular accident
- any relevant psychiatric illness, including major depression
- advanced cognitive deterioration, dementia
- other neurodegenerative diseases (i.e. Parkinson's disease)
- any chronic illness expected to shorten survival (heart, liver, cancer, etc)
- bereavement in the first year of loss
- bad dentures unless fixable dental prostheses are used
- allergy to walnuts
- customary us of fish oil or flaxseed oil supplements
- eye related exclusion criteria
We found this trial at
2
sites
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