title: National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Cardiovascular disease has a multifactorial aetiology with a number of both modifiable and non-modifiable risk factors. Although evidence indicates that dietary intake plays an important role, few studies have focused on the effect of fruit and vegetable consumption on early markers of vascular function. Therefore, we hypothesised that supplementation with capsules containing a combination of fruit and vegetable extracts over 12 weeks can significantly modulate biomarkers of vascular function compared with a control group receiving placebo.
  
  
  METHODS
  This is a double-blind, randomised controlled trial that includes overweight and obese but otherwise healthy participants. Participants are randomly allocated to one of two groups: active supplementation (encapsulated fruit and vegetable powder) or placebo taken twice daily for 12 weeks, whereas both groups will be given the '5-A-Day' dietary advice. The primary outcome is to measure changes to the carotid intima media thickness (cIMT) between the two groups from baseline (test visit 1) to 12 weeks later (test visit 2). The secondary outcomes include macro- and microvascular changes and changes to blood markers.
  
  
  CONCLUSIONS
  In addition to the primary and secondary objectives, this explanatory trial incorporates potential novel biomarkers such as trimethylamine-N-oxide (TMAO) and lipopolysaccharide (LPS).
  
  
  BACKGROUND
  ISRCTN14315618. Registration date 27 February 2014.
authors: Medical Research Council (MRC) Human Nutrition Research Unit, Cambridge, UK. marietta.sayegh@mrc-hnr.cam.ac.uk.|The Need for Nutrition Education/Innovation Programme (NNEdPro), University of Cambridge, Cambridge, UK. marietta.sayegh@mrc-hnr.cam.ac.uk.
authors: Marietta
authors: M
authors: Sayegh
authors: Medical Research Council (MRC) Human Nutrition Research Unit, Cambridge, UK. melina.tsiountsioura@mrc-hnr.cam.ac.uk.
authors: Melina
authors: M
authors: Tsiountsioura
authors: Medical Research Council (MRC) Human Nutrition Research Unit, Cambridge, UK. polly.page@mrc-hnr.cam.ac.uk.
authors: Polly
authors: P
authors: Page
authors: Medical Research Council (MRC) Human Nutrition Research Unit, Cambridge, UK. daniele.delrio@unipr.it.|The Need for Nutrition Education/Innovation Programme (NNEdPro), University of Cambridge, Cambridge, UK. daniele.delrio@unipr.it.|Department of Food Science, University of Parma, Parma, Italy. daniele.delrio@unipr.it.
authors: Dan
authors: D
authors: Del Rio
authors: Medical Research Council (MRC) Human Nutrition Research Unit, Cambridge, UK. sumantra.ray@mrc-hnr.cam.ac.uk.|The Need for Nutrition Education/Innovation Programme (NNEdPro), University of Cambridge, Cambridge, UK. sumantra.ray@mrc-hnr.cam.ac.uk.
authors: Sumantra
authors: S
authors: Ray
mesh_terms: D000328:Adult; D000368:Aged; D059168:Carotid Intima-Media Thickness; D002985:Clinical Protocols; D019587:Dietary Supplements; D004311:Double-Blind Method; D005638:Fruit; D006801:Humans; D008070:Lipopolysaccharides / Q000097:blood; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010936:Plant Extracts / Q000008:administration & dosage*; D063177:Pulse Wave Analysis; D014664:Vasodilation / Q000187:drug effects*; D014675:Vegetables
chemical_list: D008070:Lipopolysaccharides; D010936:Plant Extracts