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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 : September 23, 2019
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Joan Sabate,DrPH, MD, Loma Linda University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age Related Cognitive Decline Age Related Macular Degeneration Dietary Supplement: Walnuts Other: habitual diet Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 60g (1 to 2 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




Primary Outcome Measures :
  1. 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).


  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Change in carotid Intima-media thickness (mm) [ Time Frame: 2 years ]
    Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.

  2. 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.

  3. Change in carotid atheroma plaque height (mm) [ Time Frame: 2 years ]
    Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.

  4. 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

  5. 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

  6. Change in total fat (g) [ Time Frame: 2 years ]
    Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.

  7. Change in Total lean tissue (g) [ Time Frame: 2 years ]
    Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.

  8. Change in fasting serum total cholesterol (mg/dL) [ Time Frame: 2 years ]
    Fasting serum total cholesterol will be measured by a standard enzymatic method

  9. Change in fasting serum LDL-cholesterol (mg/dL) [ Time Frame: 2 years ]
    Fasting serum LDL-cholesterol will be estimated by the Friedewald formula

  10. Change in fasting serum HDL-cholesterol (mg/dL) [ Time Frame: 2 years ]
    Fasting serum HDL-cholesterol will be measured by a precipitation technique

  11. Change in fasting serum triglycerides (mg/dL) [ Time Frame: 2 years ]
    Fasting triglycerides will be measured by a standard enzymatic method

  12. Change in serum brain-derived neurotrophic factor (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  13. Change in serum soluble-Selectin (ng/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  14. Change in serum soluble-intercellular Adhesion Molecule 1 (ng/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  15. Change in serum soluble-vascular cell adhesion molecule 1 (ng/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  16. Change in serum amyloid A (ng/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  17. Change in serum granulocyte-macrophage colony-stimulating factor (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  18. Change in serum interferon-gamma (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  19. Change in serum interleukin-1beta (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  20. Change in serum interleukin-6 (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA

  21. Change in serum tumor necrosis factor alpha (pg/mL) [ Time Frame: 2 years ]
    Assessed by ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   63 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Loma Linda University, Department of Nutrition
Loma Linda, California, United States, 92350
Spain
Hospital Clinic, University of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Loma Linda University
University of Barcelona
Investigators
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Principal Investigator: Joan Sabate, MD, DrPH Chair, Department of Nutrition
Principal Investigator: Emilio Ros, MD, PhD Director Lipid Clinic, Endocrinology & Nutrition Service
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: September 23, 2019
Last Verified: September 2019
Keywords provided by Joan Sabate,DrPH, MD, Loma Linda University:
walnuts
age related cognitive decline
age related macular degeneration
healthy elderly subjects
Additional relevant MeSH terms:
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Macular Degeneration
Cognitive Dysfunction
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders