Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or Other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial
Chew EY, Clemons TE, Agrón E, Launer LJ, Grodstein F, Bernstein PS, Age-Related Eye Disease Study 2 (AREDS2) Research Group
JAMA · 156 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institutes of Health
- Gobierno
- U.S. Public Health Service
- Gobierno
- National Eye Institute
- Gobierno
- NEI NIH HHS
- Gobierno
- Intramural NIH HHS
- Gobierno
- PHS HHS
- Subvenciones
- National Eye Institute (ZIAEY000485); National Institutes of Health (Z99 EY999999); U.S. Public Health Service (HHS-N-260-2005-00007-C); National Eye Institute (N01-EY-5-0007)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2015-08-25 · JAMA · vol. 314 · número 8 · pág. 791
- Editorial
- American Medical Association
- Citado
- 191 citas · más que el 100% de estudios similares · 17.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Fatty Acid Research and Health · Dementia and Cognitive Impairment Research · Retinal Diseases and Treatments
- Palabras clave
- 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
- humans, macular degeneration, copper, zinc oxide, ascorbic acid, beta carotene, lutein, fatty acids, omega-3, docosahexaenoic acids, eicosapentaenoic acid, vitamins, double-blind method, cognition, neuropsychological tests, algorithms, time factors, dietary supplements, aged, aged, 80 and over, middle aged, female, male, medication adherence, lost to follow-up, zeaxanthins, outcome assessment, health care, hispanic or latino, racial groups
6 autores
- Emily Y. Chew🇺🇸 · autor de correspondenciaNational Institutes of Health; National Eye Institute
- Traci E. Clemons🇺🇸Emmes (United States)
- Elvira Agrón🇺🇸National Institutes of Health; National Eye Institute
- Lenore J. Launer🇺🇸National Institutes of Health; National Institute on Aging
- Francine Grodstein🇺🇸Brigham and Women's Hospital; Harvard University
- Paul S. Bernstein🇺🇸University of Utah
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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