Protocol and recruitment results from a 13-week randomized controlled trial comparing the effects of different doses of nitrate-rich beetroot juice on cognition, cerebral blood flow and peripheral vascular function in overweight and obese older people.

Beetroot juice Blood pressure Cerebral blood flow Cognition Inorganic nitrate Older adults

Journal

Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157

Informations de publication

Date de publication:
Jun 2020
Historique:
received: 24 12 2019
revised: 11 03 2020
accepted: 19 04 2020
entrez: 15 5 2020
pubmed: 15 5 2020
medline: 15 5 2020
Statut: epublish

Résumé

Nitrate-rich food can increase NO production and may induce positive effects on brain function. This study examined the feasibility of a randomized clinical trial (RCT) testing the effects of prolonged consumption of incremental doses of dietary nitrate (NO This was a single blind, four-arm parallel RCT conducted in 60 overweight and obese older participants. Eligible participants were randomized to:1) high NO Participant recruitment started in July 2018 and ended in April 2019. Of all the recruitment strategies that were used, advertisement of the study via Facebook generated the highest response rate. Sixty-two participants consented and were enrolled. Overall, characteristics of included participants matched our recruitment criteria. The findings from this study provide evidence of the acceptability and feasibility of an intervention investigating the effects of incremental doses of high-nitrate BJ over a prolonged period. The intervention study was registered with clinical trial ISRCTN registry (ISRCTN14746723) on 27 December 2018.

Sections du résumé

BACKGROUND BACKGROUND
Nitrate-rich food can increase NO production and may induce positive effects on brain function. This study examined the feasibility of a randomized clinical trial (RCT) testing the effects of prolonged consumption of incremental doses of dietary nitrate (NO
METHODS METHODS
This was a single blind, four-arm parallel RCT conducted in 60 overweight and obese older participants. Eligible participants were randomized to:1) high NO
RESULTS RESULTS
Participant recruitment started in July 2018 and ended in April 2019. Of all the recruitment strategies that were used, advertisement of the study via Facebook generated the highest response rate. Sixty-two participants consented and were enrolled. Overall, characteristics of included participants matched our recruitment criteria.
CONCLUSION CONCLUSIONS
The findings from this study provide evidence of the acceptability and feasibility of an intervention investigating the effects of incremental doses of high-nitrate BJ over a prolonged period.
TRIAL REGISTRATION BACKGROUND
The intervention study was registered with clinical trial ISRCTN registry (ISRCTN14746723) on 27 December 2018.

Identifiants

pubmed: 32405570
doi: 10.1016/j.conctc.2020.100571
pii: S2451-8654(20)30055-7
pii: 100571
pmc: PMC7212182
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100571

Subventions

Organisme : Medical Research Council
ID : MR/P020941/1
Pays : United Kingdom

Informations de copyright

© 2020 The Authors.

Déclaration de conflit d'intérêts

The authors have no conflict of interest to declare.

Références

Hum Psychopharmacol. 2010 Aug;25(6):448-61
pubmed: 20737518
Physiol Behav. 2015 Oct 1;149:149-58
pubmed: 26037632
Front Physiol. 2018 Mar 14;9:169
pubmed: 29593548
Nutrients. 2017 Feb 09;9(2):
pubmed: 28208763
Nitric Oxide. 2018 Jun 19;78:113-120
pubmed: 29928990
Rapid Commun Mass Spectrom. 2008 Dec;22(24):4158-64
pubmed: 19039799
Pharmacol Biochem Behav. 2003 May;75(2):329-34
pubmed: 12873623
Annu Rev Nutr. 2013;33:129-59
pubmed: 23642194
Am J Clin Nutr. 2010 Jun;91(6):1590-7
pubmed: 20357044
J Geriatr Cardiol. 2011 Dec;8(4):230-42
pubmed: 22783310
Am J Physiol Regul Integr Comp Physiol. 2013 Jan 15;304(2):R73-83
pubmed: 23174856
J Nutr. 2013 Jun;143(6):818-26
pubmed: 23596162
Crit Rev Food Sci Nutr. 2019;59(15):2400-2410
pubmed: 29617153
Stat Methods Med Res. 2016 Jun;25(3):1057-73
pubmed: 26092476
Physiol Meas. 2000 May;21(2):333-40
pubmed: 10847199
JMIR Res Protoc. 2018 Jan 24;7(1):e20
pubmed: 29367186
J Gerontol A Biol Sci Med Sci. 2010 Oct;65(10):1028-41
pubmed: 20576649
J Hypertens. 2017 Dec;35(12):2527-2531
pubmed: 28704263
Nitric Oxide. 2011 Jan 1;24(1):34-42
pubmed: 20951824
Nitric Oxide. 2015 Jan 30;44:24-30
pubmed: 25461274
Front Hum Neurosci. 2013 Aug 13;7:473
pubmed: 23964231
Vaccine. 2010 Jan 22;28(4):901-6
pubmed: 19944149
J Hypertens. 2011 Aug;29(8):1515-27
pubmed: 21720276
Int J Hypertens. 2016;2016:6791519
pubmed: 27088010
JAMA. 2018 Aug 21;320(7):657-664
pubmed: 30140876
Nutrients. 2015 Apr 14;7(4):2801-22
pubmed: 25875121
Nitric Oxide. 2012 May 15;26(4):217-22
pubmed: 22426034
J Vasc Res. 2002 Sep-Oct;39(5):447-55
pubmed: 12297707
Med Sci Monit. 2009 Apr;15(4):RA91-101
pubmed: 19333216

Auteurs

Abrar M Babateen (AM)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
Faculty of Applied Medical Sciences, Clinical Nutrition Department, Umm Al-Qura University, Makkah, Saudi Arabia.

Sofia Rubele (S)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.

Oliver Shannon (O)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.

Edward Okello (E)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
Translational and Clinical Research Institute, Newcastle University, UK.

Ellen Smith (E)

Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.

Nicholas McMahon (N)

School of Human Movement and Nutrition Sciences, University of Queensland, St. Lucia, QLD, Australia.

Gerry O'Brien (G)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.

Emma Wightman (E)

Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.

David Kennedy (D)

Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon-Tyne, NE1 8ST, UK.

John C Mathers (JC)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.

Mario Siervo (M)

Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
School of Life Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, UK.

Classifications MeSH