Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
708 participants
INTERVENTIONAL
2012-04-30
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Walnut group
This group will have their habitual diet supplemented with 30 to 45g (1 to 1.5 oz) of walnuts daily.
Walnuts
30 to 60g (1 to 2 oz) per day of walnuts
Control group
This group will eat their habitual diet and refrain from eating walnuts.
habitual diet
Dietary information will be provided
Interventions
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Walnuts
30 to 60g (1 to 2 oz) per day of walnuts
habitual diet
Dietary information will be provided
Eligibility Criteria
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Inclusion Criteria
* healthy men and women
* able to attend clinic at a study sites
Exclusion Criteria
* 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
63 Years
79 Years
ALL
Yes
Sponsors
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University of Barcelona
OTHER
California Walnut Commission
OTHER
Loma Linda University
OTHER
Responsible Party
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Joan Sabate,DrPH, MD
Principal Investigator, Chair, Department of Nutrition
Principal Investigators
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Joan Sabate, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Chair, Department of Nutrition
Emilio Ros, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Director Lipid Clinic, Endocrinology & Nutrition Service
Locations
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Loma Linda University, Department of Nutrition
Loma Linda, California, United States
Hospital Clinic, University of Barcelona
Barcelona, , Spain
Countries
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References
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Cofan M, Checa A, Serra-Mir M, Roth I, Valls-Pedret C, Lopez-Illamola A, Domenech M, Rajaram S, Lazaro I, Sabate J, Ros E, Wheelock CE, Sala-Vila A. A Walnut-Enriched Diet for 2 Years Changes the Serum Oxylipin Profile in Healthy Older Persons. J Nutr. 2024 Feb;154(2):395-402. doi: 10.1016/j.tjnut.2023.12.007. Epub 2023 Dec 9.
Fjell AM, Sorensen O, Wang Y, Amlien IK, Baare WFC, Bartres-Faz D, Boraxbekk CJ, Brandmaier AM, Demuth I, Drevon CA, Ebmeier KP, Ghisletta P, Kievit R, Kuhn S, Madsen KS, Nyberg L, Sole-Padulles C, Vidal-Pineiro D, Wagner G, Watne LO, Walhovd KB. Is Short Sleep Bad for the Brain? Brain Structure and Cognitive Function in Short Sleepers. J Neurosci. 2023 Jul 12;43(28):5241-5250. doi: 10.1523/JNEUROSCI.2330-22.2023. Epub 2023 Jun 26.
Nyberg L, Magnussen F, Lundquist A, Baare W, Bartres-Faz D, Bertram L, Boraxbekk CJ, Brandmaier AM, Drevon CA, Ebmeier K, Ghisletta P, Henson RN, Junque C, Kievit R, Kleemeyer M, Knights E, Kuhn S, Lindenberger U, Penninx BWJH, Pudas S, Sorensen O, Vaque-Alcazar L, Walhovd KB, Fjell AM. Educational attainment does not influence brain aging. Proc Natl Acad Sci U S A. 2021 May 4;118(18):e2101644118. doi: 10.1073/pnas.2101644118.
Fjell AM, Sorensen O, Amlien IK, Bartres-Faz D, Brandmaier AM, Buchmann N, Demuth I, Drevon CA, Duzel S, Ebmeier KP, Ghisletta P, Idland AV, Kietzmann TC, Kievit RA, Kuhn S, Lindenberger U, Magnussen F, Macia D, Mowinckel AM, Nyberg L, Sexton CE, Sole-Padulles C, Pudas S, Roe JM, Sederevicius D, Suri S, Vidal-Pineiro D, Wagner G, Watne LO, Westerhausen R, Zsoldos E, Walhovd KB. Poor Self-Reported Sleep is Related to Regional Cortical Thinning in Aging but not Memory Decline-Results From the Lifebrain Consortium. Cereb Cortex. 2021 Mar 5;31(4):1953-1969. doi: 10.1093/cercor/bhaa332.
Sorensen O, Brandmaier AM, Macia D, Ebmeier K, Ghisletta P, Kievit RA, Mowinckel AM, Walhovd KB, Westerhausen R, Fjell A. Meta-analysis of generalized additive models in neuroimaging studies. Neuroimage. 2021 Jan 1;224:117416. doi: 10.1016/j.neuroimage.2020.117416. Epub 2020 Oct 2.
Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.
Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.
Sala-Vila A, Valls-Pedret C, Rajaram S, Coll-Padros N, Cofan M, Serra-Mir M, Perez-Heras AM, Roth I, Freitas-Simoes TM, Domenech M, Calvo C, Lopez-Illamola A, Bitok E, Buxton NK, Huey L, Arechiga A, Oda K, Lee GJ, Corella D, Vaque-Alcazar L, Sala-Llonch R, Bartres-Faz D, Sabate J, Ros E. Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial. Am J Clin Nutr. 2020 Mar 1;111(3):590-600. doi: 10.1093/ajcn/nqz328.
Bartres-Faz D, Gonzalez-Escamilla G, Vaque-Alcazar L, Abellaneda-Perez K, Valls-Pedret C, Ros E, Grothe MJ. Characterizing the Molecular Architecture of Cortical Regions Associated with High Educational Attainment in Older Individuals. J Neurosci. 2019 Jun 5;39(23):4566-4575. doi: 10.1523/JNEUROSCI.2370-18.2019. Epub 2019 Apr 8.
Domenech M, Serra-Mir M, Roth I, Freitas-Simoes T, Valls-Pedret C, Cofan M, Lopez A, Sala-Vila A, Calvo C, Rajaram S, Sabate J, Ros E. Effect of a Walnut Diet on Office and 24-Hour Ambulatory Blood Pressure in Elderly Individuals. Hypertension. 2019 May;73(5):1049-1057. doi: 10.1161/HYPERTENSIONAHA.118.12766.
Freitas-Simoes TM, Cofan M, Blasco MA, Soberon N, Foronda M, Corella D, Asensio EM, Serra-Mir M, Roth I, Calvo C, Valls-Pedret C, Casaroli-Marano RP, Domenech M, Rajaram S, Sabate J, Ros E, Sala-Vila A. The red blood cell proportion of arachidonic acid relates to shorter leukocyte telomeres in Mediterranean elders: A secondary analysis of a randomized controlled trial. Clin Nutr. 2019 Apr;38(2):958-961. doi: 10.1016/j.clnu.2018.02.011. Epub 2018 Feb 17.
Rajaram S, Valls-Pedret C, Cofan M, Sabate J, Serra-Mir M, Perez-Heras AM, Arechiga A, Casaroli-Marano RP, Alforja S, Sala-Vila A, Domenech M, Roth I, Freitas-Simoes TM, Calvo C, Lopez-Illamola A, Haddad E, Bitok E, Kazzi N, Huey L, Fan J, Ros E. The Walnuts and Healthy Aging Study (WAHA): Protocol for a Nutritional Intervention Trial with Walnuts on Brain Aging. Front Aging Neurosci. 2017 Jan 10;8:333. doi: 10.3389/fnagi.2016.00333. eCollection 2016.
Fernandez-Cabello S, Valls-Pedret C, Schurz M, Vidal-Pineiro D, Sala-Llonch R, Bargallo N, Ros E, Bartres-Faz D. White matter hyperintensities and cognitive reserve during a working memory task: a functional magnetic resonance imaging study in cognitively normal older adults. Neurobiol Aging. 2016 Dec;48:23-33. doi: 10.1016/j.neurobiolaging.2016.08.008. Epub 2016 Aug 20.
Vaque-Alcazar L, Sala-Llonch R, Valls-Pedret C, Vidal-Pineiro D, Fernandez-Cabello S, Bargallo N, Ros E, Bartres-Faz D. Differential age-related gray and white matter impact mediates educational influence on elders' cognition. Brain Imaging Behav. 2017 Apr;11(2):318-332. doi: 10.1007/s11682-016-9584-8.
Other Identifiers
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670715-3833
Identifier Type: OTHER
Identifier Source: secondary_id
5120066
Identifier Type: -
Identifier Source: org_study_id
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