Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: Observational data have suggested that high dietary intake of saturated fat and low intake of vegetables may be associated with increased risk of Alzheimer disease. OBJECTIVE: To test the effects of oral supplementation with nutrients on cognitive function. DESIGN, SETTING, AND PARTICIPANTS: In a double-masked randomized clinical trial (the Age-Related Eye Disease Study 2 [AREDS2]), retinal specialists in 82 US academic and community medical centers enrolled and observed participants who were at risk for developing late age-related macular degeneration (AMD) from October 2006 to December 2012. In addition to annual eye examinations, several validated cognitive function tests were administered via telephone by trained personnel at baseline and every 2 years during the 5-year study. INTERVENTIONS: Long-chain polyunsaturated fatty acids (LCPUFAs) (1 g) and/or lutein (10 mg)/zeaxanthin (2 mg) vs placebo were tested in a factorial design. All participants were also given varying combinations of vitamins C, E, beta carotene, and zinc. MAIN OUTCOMES AND MEASURES: The main outcome was the yearly change in composite scores determined from a battery of cognitive function tests from baseline. The analyses, which were adjusted for baseline age, sex, race, history of hypertension, education, cognitive score, and depression score, evaluated the differences in the composite score between the treated vs untreated groups. The composite score provided an overall score for the battery, ranging from -22 to 17, with higher scores representing better function. RESULTS: A total of 89% (3741/4203) of AREDS2 participants consented to the ancillary cognitive function study and 93.6% (3501/3741) underwent cognitive function testing. The mean (SD) age of the participants was 72.7 (7.7) years and 57.5% were women. There were no statistically significant differences in change of scores for participants randomized to receive supplements vs those who were not. The yearly change in the composite cognitive function score was -0.19 (99% CI, -0.25 to -0.13) for participants randomized to receive LCPUFAs vs -0.18 (99% CI, -0.24 to -0.12) for those randomized to no LCPUFAs (difference in yearly change, -0.03 [99% CI, -0.20 to 0.13]; P = .63). Similarly, the yearly change in the composite cognitive function score was -0.18 (99% CI, -0.24 to -0.11) for participants randomized to receive lutein/zeaxanthin vs -0.19 (99% CI, -0.25 to -0.13) for those randomized to not receive lutein/zeaxanthin (difference in yearly change, 0.03 [99% CI, -0.14 to 0.19]; P = .66). Analyses were also conducted to assess for potential interactions between LCPUFAs and lutein/zeaxanthin and none were found to be significant. CONCLUSIONS AND RELEVANCE: Among older persons with AMD, oral supplementation with LCPUFAs or lutein/zeaxanthin had no statistically significant effect on cognitive function. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00345176.
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In the AREDS2 study, dietary intervention with 350 mg DHA and 650 mg EPA for 5 years did not have a significant effect on cognitive function in 3,501 older adults with age-related macular degeneration.
“In the AREDS2 study, dietary intervention with 350 mg DHA and 650 mg EPA for 5 years did not have a significant effect on cognitive function in 3,501 older adults (mean age 72.7 years) with age-related macular degeneration [74].”
From Role of n-3 long-chain polyunsaturated fatty acids in human nutrition and health: Review of recent studies and recommendations (2021) · cites this paper as [74]
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Sun, R., Wang, J., Feng, J., & Cao, B. (2022) · Biomolecules · doi:10.3390/biom12071000 · Cited by 61 · see citing works
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“Results from studies investigating the effects of supplementation or increasing dietary intake of lutein and zeaxanthin on cognition in a healthy elderly population have been contradictory, with some showing a beneficial effect on cognitive performance (19,20), and others finding no effect (21,22).”
BackgroundResultAbdullah, L. I., Evans, J. E., Emmerich, T., Crynen, G. C., Shackleton, B., Keegan, A. P., Luis, C. A., Tai, L. M., LaDu, M. J., MULLAN, M. J., et al. (2017) · Aging · doi:10.18632/aging.101203 · Cited by 60 · see citing works
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“Nevertheless, a recent randomized controlled trial of >3,000 participants with age-related macular degeneration (AREDS2 study) showed that supplementation with omega-3 fatty acids and lutein/zeaxanthin had no significant effect on cognitive function.(30)”
BackgroundOxidative Stress and Microglial Response in Retinitis Pigmentosa
Murakami, Y., Nakabeppu, Y., & Sonoda, K. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21197170 · Cited by 56 · see citing works
A Comprehensive Review of Eggs, Choline, and Lutein on Cognition Across the Life-span
Wallace, T. C. (2018) · Journal of the American College of Nutrition · doi:10.1080/07315724.2017.1423248 · Cited by 54 · see citing works
Lipophilic antioxidants in neurodegenerative diseases
Chang, K., Cheng, M., Chiang, M.-C., & Chen, C. (2018) · Clinica Chimica Acta · doi:10.1016/j.cca.2018.06.031 · Cited by 55 · see citing works
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Acyl-CoA synthetases as regulators of brain phospholipid acyl-chain diversity
Fernandez, R. F., & Ellis, J. M. (2020) · Prostaglandins Leukotrienes and Essential Fatty Acids · doi:10.1016/j.plefa.2020.102175 · Cited by 52 · see citing works
Zinc Therapy in Early Alzheimer’s Disease: Safety and Potential Therapeutic Efficacy
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Prevention of cognitive impairment: scientific guidance and windows of opportunity
Gorelick, P. B. (2017) · Journal of Neurochemistry · doi:10.1111/jnc.14113 · Cited by 49 · see citing works
“Other select interventional studies that focused mainly on a single intervention (e.g., exercise or oral supplementation with nutrients) have not resulted in significant improvements in cognition (Chew et al. 2015; Sink et al. 2015).”
BackgroundLopresti, A. L., Smith, S. J., & Drummond, P. D. (2022) · Frontiers in Nutrition · doi:10.3389/fnut.2022.843512 · Cited by 48 · see citing works
“However, in a large 5-year study on older-age adults with intermediate or advanced age-related macular degeneration, lutein and zeaxanthin supplementation did not change cognitive function as measured by several telephone-administered cognitive tasks (24).”
BackgroundMedicinal plants and natural products as neuroprotective agents in age-related macular degeneration
Bosch‐Morell, F., Villagrasa, V., Ortega, T., Acero, N., Mingarro, D. M., González‐Rosende, M. E., Castillo, E., Sanahuja, M. A., Soriano, P., & Martínez‐Solís, I. (2020) · Neural Regeneration Research · doi:10.4103/1673-5374.284978 · Cited by 47 · see citing works
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A Review of the Role of the Intestinal Microbiota in Age-Related Macular Degeneration
Lin, P., McClintic, S. M., Nadeem, U., & Skondra, D. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10102072 · Cited by 48 · see citing works
“While analysis of the role of nutritional factors is notoriously difficult, an oral supplement containing the carotenoids lutein and zeaxanthin, or beta-carotene (original formulation), minerals, and antioxidants was found by the Age-Related Eye Disease Studies (AREDS and AREDS2) to reduce the risk of AMD progression…”
BackgroundRangel-Huerta, Ó. D., & Gil, Á. (2017) · Nutrition Reviews · doi:10.1093/nutrit/nux064 · Cited by 47 · see citing works
Zhou, X., Wang, S., Ding, X., Li, Q., Mao, Y., Chen, L., Li, W., & Ying, C. (2017) · Brain Research Bulletin · doi:10.1016/j.brainresbull.2017.06.001 · Cited by 45 · see citing works
Dietary total antioxidant capacity in relation to depression and anxiety in Iranian adults
Milajerdi, A., Keshteli, A. H., Afshar, H., Esmaillzadeh, A., & Adibi, P. (2018) · Nutrition · doi:10.1016/j.nut.2018.11.017 · Cited by 46 · see citing works
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Modulation of innate immunity of patients with Alzheimer's disease by omega‐3 fatty acids
Fiala, M., Kooij, G., Wagner, K. M., Hammock, B. D., & Pellegrini, M. A. (2017) · The FASEB Journal · doi:10.1096/fj.201700065r · Cited by 44 · see citing works
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The Potential Uses of Omega-3 Fatty Acids in Dermatology: A Review
Thomsen, B. J., Chow, E. Y., & Sapijaszko, M. (2020) · Journal of Cutaneous Medicine and Surgery · doi:10.1177/1203475420929925 · Cited by 42 · see citing works
Unified theory of Alzheimer’s disease (UTAD): implications for prevention and curative therapy
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“Another reason for the increase of n-6 PUFAs in our modern diet results from the intense consumption of meat and high fat milk products.”
BackgroundInfluentialSuh, S. W., Lim, E., Burm, S.-Y., Lee, H., Bae, J. B., Han, J. W., & Kim, K. W. (2024) · BMC Medicine · doi:10.1186/s12916-024-03296-0 · Cited by 41 · see citing works
Enriched Brain Omega-3 Polyunsaturated Fatty Acids Confer Neuroprotection against Microinfarction
Luo, C., Ren, H., Yao, X., Shi, Z., Liang, F., Kang, J. X., Wan, J., Pei, Z., Su, K., & Su, H. (2018) · EBioMedicine · doi:10.1016/j.ebiom.2018.05.028 · Cited by 41 · see citing works
“A large clinical trial with 4000 patients included showed that ω-3 PUFAs supplements did not slow cognitive decline in older people [8].”
BackgroundKeenan, T. D. L., Agrón, E., Mares, J. A., Clemons, T. E., van Asten, F., Swaroop, A., & Chew, E. Y. (2020) · Alzheimer s & Dementia · doi:10.1002/alz.12077 · Cited by 41 · see citing works
Self-citationNon-Enzymatic Antioxidants against Alzheimer’s Disease: Prevention, Diagnosis and Therapy
Varesi, A., Campagnoli, L. I. M., Carrara, A., Pola, I., Floris, E., Ricevuti, G., Chirumbolo, S., & Pascale, A. (2023) · Antioxidants · doi:10.3390/antiox12010180 · Cited by 45 · see citing works
“Nevertheless, results from the “Age-Related Eye Disease Study 2” (AREDS2) randomized trial report no significant benefits of lutein and zeaxanthin supplementation in terms of cognitive performance among individuals with a high risk of AMD development [75].”
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van Asten, F., Simmons, M., Singhal, A., Keenan, T. D. L., Ratnapriya, R., Agrón, E., Clemons, T. E., Swaroop, A., Lu, Z., & Chew, E. Y. (2017) · Ophthalmology · doi:10.1016/j.ophtha.2017.09.023 · Cited by 38 · see citing works
Self-citationCognitive function in patients with coronary artery disease: A literature review
Burkauskas, J., Lang, P., Bunevičius, A., Neverauskas, J., Bučiūtė-Jankauskienė, M., & Mickuvienė, N. (2018) · Journal of International Medical Research · doi:10.1177/0300060517751452 · Cited by 39 · see citing works
Kuszewski, J. C., Wong, R. H. X., & Howe, P. R. C. (2017) · Nutrients · doi:10.3390/nu9050487 · Cited by 37 · see citing works
Therapeutic Opportunities for Food Supplements in Neurodegenerative Disease and Depression
Businaro, R., Vauzour, D., Sarris, J. J., Münch, G. W., Gyengési, E., Brogelli, L., & Zuzarte, P. (2021) · Frontiers in Nutrition · doi:10.3389/fnut.2021.669846 · Cited by 41 · see citing works
Nerve Growth Factor-Based Therapy in Alzheimer’s Disease and Age-Related Macular Degeneration
Amadoro, G., Latina, V., Balzamino, B. O., Squitti, R., Varano, M., Calissano, P., & Micera, A. (2021) · Frontiers in Neuroscience · doi:10.3389/fnins.2021.735928 · Cited by 40 · see citing works
Screening for Impaired Visual Acuity in Older Adults
Chou, R., Bougatsos, C., Jungbauer, R., Grusing, S., Blazina, I., Selph, S., Jonas, D. E., & Tehrani, S. (2022) · JAMA · doi:10.1001/jama.2022.6381 · Cited by 36 · see citing works
The Emerging Role of Gut Microbiota in Age-Related Macular Degeneration
Xiao, J. F., Zhang, J. Y., Luo, W., He, P. C., & Skondra, D. (2023) · American Journal Of Pathology · doi:10.1016/j.ajpath.2023.04.006 · Cited by 36 · see citing works
“53 e 55 Although the protective mechanisms of these compounds are not completely understood, their impact on the intestinal microbiome and interactions with speci fi c microbiota may be essential to their bioavailability and bene fi cial effects.”
BackgroundImpact of a high-fat diet on the fatty acid composition of the retina
Albouery, M., Buteau, B., Gregoire, S., Martine, L., Gambert, S., Bron, A. M., Acar, N., Chassaing, B., & Bringer, M.-A. (2020) · Experimental Eye Research · doi:10.1016/j.exer.2020.108059 · Cited by 35 · see citing works
Role of nutraceuticals in cognition during aging and related disorders
Singh, P., Sivanandam, T. M., Konar, A., & Thakur, M. K. (2020) · Neurochemistry International · doi:10.1016/j.neuint.2020.104928 · Cited by 35 · see citing works
Microglia and modifiable life factors: Potential contributions to cognitive resilience in aging
Duggan, M. R., & Parikh, V. (2021) · Behavioural Brain Research · doi:10.1016/j.bbr.2021.113207 · Cited by 36 · see citing works
Lenin, R. R., Koh, Y., Zhang, Z., Yeo, Y., Parikh, B. H., Seah, I. Y. J., Wong, W., & Su, X. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24108763 · Cited by 33 · see citing works
“NCT00345176 was a controlled randomised clinical trial, where the participants were evaluated to have high risk of progression to late AMD [75].”
BackgroundDietary Lutein and Cognitive Function in Adults: A Meta-Analysis of Randomized Controlled Trials
Li, J., & Abdel‐Aal, E. M. (2021) · Molecules · doi:10.3390/molecules26195794 · Cited by 36 · see citing works
“[43] and small sample size of the other two studies [39,45].”
BackgroundMethodResultInfluentialSantos, F. M., Ciordia, S., Mesquita, J., Sousa, J. P. C., Paradela, A., Tomaz, C. T., & Passarinha, L. A. (2022) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-022-04670-y · Cited by 33 · see citing works
Diabetes, Edentulism, and Cognitive Decline: A 12-Year Prospective Analysis
Wu, B., Luo, H., Tan, C., Qi, X., Sloan, F. A., Kamer, A. R., Schwartz, M. D., Martinez, M., & Plassman, B. L. (2023) · Journal of Dental Research · doi:10.1177/00220345231155825 · Cited by 33 · see citing works
“…to changes in dietary intake and diversity (De Marchi et al. 2008); DM-related impaired glucose tolerance and insulin sensitivity (Ojo and Brooke 2015) could partially contribute to a nutritional deficiency—all of which are risk factors for cognitive impairment and dementia (Chew et al. 2015).”
BackgroundMao, D.-S., Tao, B., Sheng, S.-Y., Jin, H.-L., Chen, W., Gao, H., Deng, J., Li, Z., Chen, F., Chan, S., et al. (2023) · Investigative Ophthalmology and Visual Science · doi:10.1167/iovs.64.12.32 · Cited by 30 · see citing works
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Dietary Interventions to Prevent or Delay Alzheimer’s Disease: What the Evidence Shows
Bartochowski, Z., Conway, J., Wallach, Y., Chakkamparambil, B., Alakkassery, S., & Grossberg, G. T. (2020) · Current Nutrition Reports · doi:10.1007/s13668-020-00333-1 · Cited by 30 · see citing works
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Controversies in omega-3 efficacy and novel concepts for application
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A Review of the Impact of Alterations in Gut Microbiome on the Immunopathogenesis of Ocular Diseases
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Carotenoid Supplementation for Alleviating the Symptoms of Alzheimer’s Disease
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“…supplementation with long-chain polyun-saturated fatty acids (LCPUFAs) (1 g) and/or lutein (10 mg)/zeaxanthin (2 mg) on cognitive function was reported in another double-blind, randomized clinical trial [306]. group, carotenes such as β -carotene and α -carotene, or apocarotenoid cis configuration.”
BackgroundAhmad, N., Hussain, A., Khan, S., Korma, S. A., Hussain, G., Aadil, R. M., Siddique, R., Ali, A., Shabbir, U., Haq, A. U., et al. (2021) · Food Science & Nutrition · doi:10.1002/fsn3.2236 · Cited by 23 · see citing works
“The National Institute of the United States recommended 650 mg of fish fatty acids daily (Chew et al., 2015).”
Background
- Authors
- Chew, E. Y., Clemons, T. E., Agrón, E., Launer, L. J., Grodstein, F., & Bernstein, P. S.
- Affiliations
- National Institutes of Health (US)
- Emmes (United States) (US)
- Brigham and Women's Hospital (US)
- University of Utah (US)
- Corresponding author
- Chew, Emily Y.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2015-08-25
- Volume
- 314
- Issue
- 8
- Pages
- 791
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5369607
- OpenAlex
- W2164097888
- Cited by
- 191
- References
- 29
- Citations by year
- 2026: 10 · 2025: 11 · 2024: 16 · 2023: 17 · 2022: 19 · 2021: 22 · 2020: 24 · 2019: 9 · 2018: 18 · 2017: 19 · 2016: 17 · 2015: 9
- FWCI
- 20.24
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (Z99 EY999999)
- U.S. Public Health Service (HHS-N-260-2005-00007-C)
- National Eye Institute (ZIAEY000485, N01-EY-5-0007)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Keywords
- omega-3 fatty acids, long-chain polyunsaturated fatty acids, lutein, zeaxanthin, cognitive function, age-related macular degeneration, AREDS2, dietary supplementation, vitamin E, vitamin C, beta-carotene, zinc, cognitive decline, Alzheimer's disease risk, macular pigment, older adults
- MeSH terms
- Aged, Aged, 80 and over, Algorithms, Ascorbic Acid, Cognition, Copper, Docosahexaenoic Acids, Double-Blind Method, Female, Hispanic or Latino, Humans, Macular Degeneration, Male, Middle Aged, Neuropsychological Tests, Time Factors, Vitamins, Lutein, Zinc Oxide, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Outcome Assessment, Health Care, beta Carotene, Dietary Supplements, Racial Groups, Medication Adherence, Lost to Follow-Up, Zeaxanthins
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