title: Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.
abstract: BACKGROUND
  Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) STUDY DESIGN: A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness.
  
  
  CONCLUSIONS
  The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD.
authors.affiliation: Duke University Medical Center, United States. Blume003@mc.duke.edu
authors.forename: James A
authors.initials: JA
authors.lastname: Blumenthal
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Smith
authors.forename: Kathleen
authors.initials: K
authors.lastname: Welsh-Bohmer
authors.forename: Michael A
authors.initials: MA
authors.lastname: Babyak
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Browndyke
authors.forename: Pao-Hwa
authors.initials: PH
authors.lastname: Lin
authors.forename: P Murali
authors.initials: PM
authors.lastname: Doraiswamy
authors.forename: James
authors.initials: J
authors.lastname: Burke
authors.forename: William
authors.initials: W
authors.lastname: Kraus
authors.forename: Alan
authors.initials: A
authors.lastname: Hinderliter
authors.forename: Andrew
authors.initials: A
authors.lastname: Sherwood
mesh_terms: D002318:Cardiovascular Diseases / Q000150:complications / Q000523:psychology / Q000628:therapy*; D003071:Cognition / Q000502:physiology*; D003072:Cognition Disorders / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D004035:Diet Therapy / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012307:Risk Factors