Walnuts and Healthy Aging (WAHA)
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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 |
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Recruitment Status :
Completed
First Posted : July 6, 2012
Last Update Posted : June 24, 2021
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| 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 2 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Prevention |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Walnut group
This group will have their habitual diet supplemented with 30 to 45g (1 to 1.5 oz) of walnuts daily.
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Dietary Supplement: Walnuts
30 to 60g (1 to 2 oz) per day of walnuts |
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Active Comparator: Control group
This group will eat their habitual diet and refrain from eating walnuts.
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Other: habitual diet
Dietary information will be provided |
- Changes from baseline in global cognitive composite score [ Time Frame: 2 years ]
The composite score will be calculated using the scores from the tests listed below. We will calculate the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores.
The 12 tests are: Rey Auditory Verbal Learning Test (RAVLT), Rey-Osterrieth Complex Figure (ROCF), Semantic Fluency (Animals), Boston Naming Test (BNT), Visual Object and Space Perception Battery (VOSP), Block Design section from the Wechsler Adult Intelligence Scale (WAIS-III), Trail Making Test (TMT), FAS Word Fluency, Stroop Color Word Test, Symbol Digit Modalities Test (SMDT) Digit Span from the WAIS-III and Conners Continuous Performance Test (CPT-II).
- Changes from baseline in macular degeneration [ Time Frame: 2 years ]This will be assessed: by stereoscopic digitized color fundus images graded by International Classification System for Age-Related Maculopathy (score range. 0 to 4; the higher the score, the worse the condition); by optical coherence tomography (OCT) measurements of macular thickness (in µm); by optical coherence tomography (OCT) measurements of retinal nervous fiber layer thickness (in µm).
- Change from baseline in brain cortical thickness [ Time Frame: 2 years ]Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is mm2.
- Change from baseline in voxel-based morphometry [ Time Frame: 2 years ]Changes will be assessed by brain magnetic resonance imaging (MRI) using GM density maps on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is GM density.
- Change from baseline in white matter hyperintensity volumes [ Time Frame: 2 years ]Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is mL.
- Change from baseline in perfusion arterial spin labeling [ Time Frame: 2 years ]Changes will be assessed by brain magnetic resonance imaging (MRI) on a randomly selected subset of participants. Only in Barcelona center. Unit of measure is ml/100 g/min.
- Changes from baseline in brain activation [ Time Frame: 2 years ]Changes will be assessed by Functional MRI (fMRI) on a randomly selected subset of participants. Only in Barcelona center. There are no units of measure.
- Change in carotid Intima-media thickness (mm) [ Time Frame: 2 years ]Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.
- Incidence of plaque presence in carotid artery (yes/no) [ Time Frame: 2 years ]Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.
- Change in carotid atheroma plaque height (mm) [ Time Frame: 2 years ]Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.
- Change in body mass index (kg/m2) [ Time Frame: 2 years ]BMI will be calculated as weight in kilograms divided by height in metres squared
- Change in waist circumference (cm) [ Time Frame: 2 years ]Waist circumference will be measured to the nearest 0.5 cm by using an anthropometric tape midway between the lowest rib and at the iliac crest at minimal respiration
- Change in total fat (g) [ Time Frame: 2 years ]Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.
- Change in Total lean tissue (g) [ Time Frame: 2 years ]Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.
- Change in fasting serum total cholesterol (mg/dL) [ Time Frame: 2 years ]Fasting serum total cholesterol will be measured by a standard enzymatic method
- Change in fasting serum LDL-cholesterol (mg/dL) [ Time Frame: 2 years ]Fasting serum LDL-cholesterol will be estimated by the Friedewald formula
- Change in fasting serum HDL-cholesterol (mg/dL) [ Time Frame: 2 years ]Fasting serum HDL-cholesterol will be measured by a precipitation technique
- Change in fasting serum triglycerides (mg/dL) [ Time Frame: 2 years ]Fasting triglycerides will be measured by a standard enzymatic method
- Change in serum brain-derived neurotrophic factor (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum soluble-Selectin (ng/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum soluble-intercellular Adhesion Molecule 1 (ng/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum soluble-vascular cell adhesion molecule 1 (ng/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum amyloid A (ng/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum granulocyte-macrophage colony-stimulating factor (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum interferon-gamma (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum interleukin-1beta (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum interleukin-6 (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
- Change in serum tumor necrosis factor alpha (pg/mL) [ Time Frame: 2 years ]Assessed by ELISA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 63 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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 | |
| Spain | |
| 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 |
| Responsible Party: | Joan Sabate,DrPH, MD, Principal Investigator, Chair, Department of Nutrition, Loma Linda University |
| ClinicalTrials.gov Identifier: | NCT01634841 |
| Other Study ID Numbers: |
5120066 670715-3833 ( Other Identifier: Loma Linda University ) |
| First Posted: | July 6, 2012 Key Record Dates |
| Last Update Posted: | June 24, 2021 |
| Last Verified: | June 2021 |
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walnuts age related cognitive decline age related macular degeneration healthy elderly subjects |
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Macular Degeneration Cognitive Dysfunction Retinal Degeneration Retinal Diseases |
Eye Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders |