Walnuts and Healthy Aging (WAHA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01634841|
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Age Related Cognitive Decline Age Related Macular Degeneration||Dietary Supplement: Walnuts Other: habitual diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||708 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Walnut group
This group will have their habitual diet supplemented with 30 to 45g (1 to 1.5 oz) of walnuts daily.
Dietary Supplement: Walnuts
30 to 45g (1 to 1.5 oz) per day of walnuts
Active Comparator: Control group
This group will eat their habitual diet and refrain from eating walnuts.
Other: habitual diet
Dietary information will be provided
- % Change in cognitive decline from baseline [ Time Frame: 2 years ]Baseline data will be collected using the following neuropsychological evaluations: NART, WAIS III tests of intelligence; ROCF, RAVLT for memory; BNT and semantic category evocation for language; VOSP for perception; copy ROCF for praxis; TMT A, TMT B, FAS word fluency, Stroop test, SDMT, CPT II, CANTAB for frontal cognition. From baseline we hypothesize there will be a 5% difference in cognitive decline between the walnut intervention group and the control group when tests are performed again after the 2 year intervention.
- % change in macular degeneration from baseline [ Time Frame: 2 years ]We hypothesize that 30 to 45g per day of walnuts will delay the onset and progression of macular degeneration in healthy elderly subjects. This will be determined by a difference of 5% in the thickness of the retina as measured by OCT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634841
|United States, California|
|Loma Linda University, Department of Nutrition|
|Loma Linda, California, United States, 92350|
|Hospital Clinic, University of Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Joan Sabate, MD, DrPH||Chair, Department of Nutrition|
|Principal Investigator:||Emilio Ros, MD, PhD||Director Lipid Clinic, Endocrinology & Nutrition Service|