Journal article
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/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).
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 637.4KB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-016-1185-8
Authors
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 17
- Issue:
- 1
- Pages:
- 67
- Publication date:
- 2016-02-04
- Acceptance date:
- 2016-01-18
- DOI:
- EISSN:
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1745-6215
- Pmid:
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26846357
- Language:
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English
- Keywords:
- Pubs id:
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pubs:822554
- UUID:
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uuid:13b03442-74a4-4159-957f-4b984b059f68
- Local pid:
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pubs:822554
- Source identifiers:
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822554
- Deposit date:
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2018-03-16
Terms of use
- Copyright holder:
- Sayegh et al
- Copyright date:
- 2016
- Notes:
- © 2016 Sayegh et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Licence:
- CC Attribution (CC BY)
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