National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial

Marietta Sayegh, Melina Tsiountsioura, Polly Page, Dan Del Rio, Sumantra Ray

    Research output: Contribution to journalArticle

    2 Citations (Scopus)

    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/Design: 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.
    Discussion: In addition to the primary and secondary objectives, this explanatory trial incorporates potential novel
    biomarkers such as trimethylamine-N-oxide (TMAO) and lipopolysaccharide (LPS).
    Original languageEnglish
    JournalTrials
    Volume17
    Issue number1
    DOIs
    Publication statusPublished - 4 Feb 2016

    Keywords

    • Vascular function
    • endothelial function
    • fruit and vegetable extracts
    • capsule supplementation
    • placebo
    • carotid intima media thickness
    • double-blind RCT

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