Walnuts and Healthy Aging (WAHA)

June 21, 2021 updated by: Joan Sabate,DrPH, MD, Loma Linda University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
708

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic, University of Barcelona
  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University, Department of Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

63 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 years
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).
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in carotid Intima-media thickness (mm)
Time Frame: 2 years
Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.
2 years
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.
2 years
Change in carotid atheroma plaque height (mm)
Time Frame: 2 years
Changes will be assessed by high-resolution ultrasound. Only in Barcelona center.
2 years
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
2 years
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
2 years
Change in total fat (g)
Time Frame: 2 years
Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.
2 years
Change in Total lean tissue (g)
Time Frame: 2 years
Changes will be assessed by Dual-energy X-ray absorptiometry. Only in Barcelona center.
2 years
Change in fasting serum total cholesterol (mg/dL)
Time Frame: 2 years
Fasting serum total cholesterol will be measured by a standard enzymatic method
2 years
Change in fasting serum LDL-cholesterol (mg/dL)
Time Frame: 2 years
Fasting serum LDL-cholesterol will be estimated by the Friedewald formula
2 years
Change in fasting serum HDL-cholesterol (mg/dL)
Time Frame: 2 years
Fasting serum HDL-cholesterol will be measured by a precipitation technique
2 years
Change in fasting serum triglycerides (mg/dL)
Time Frame: 2 years
Fasting triglycerides will be measured by a standard enzymatic method
2 years
Change in serum brain-derived neurotrophic factor (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum soluble-Selectin (ng/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum soluble-intercellular Adhesion Molecule 1 (ng/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum soluble-vascular cell adhesion molecule 1 (ng/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum amyloid A (ng/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum granulocyte-macrophage colony-stimulating factor (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum interferon-gamma (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum interleukin-1beta (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum interleukin-6 (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years
Change in serum tumor necrosis factor alpha (pg/mL)
Time Frame: 2 years
Assessed by ELISA
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Barcelona
California Walnut Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joan Sabate, MD, DrPH, Chair, Department of Nutrition
  • Principal Investigator: Emilio Ros, MD, PhD, Director Lipid Clinic, Endocrinology & Nutrition Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5120066
  • 670715-3833 (Other Identifier: Loma Linda University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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