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Effects of dietary nitrate and folate supplementation on blood pressure in hypertensive Tanzanians: Design and baseline characteristics of a feasibility trial

Lookup NU author(s): Dr Stella Paddick, Professor Richard Walker, Dr Mario Siervo

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2019 The Author(s)The burden of hypertension in Sub-Saharan African countries is rising. Low-cost and effective interventions are needed to mitigate these alarming trends. No evidence is available on the use of dietary nitrate for treating hypertension in African populations. The objectives of this study are to assess the feasibility and efficacy of using beetroot and folate as a combined dietary intervention to treat Tanzanian adults with pre- and mild to moderate hypertension. This was a three-arm double-blind, placebo-controlled, parallel randomised clinical trial conducted within the Hai Demographic Surveillance Site in the Kilimanjaro region in Tanzania. 48 participants were randomised to one of three groups for a 60-day intervention period. Group 1: Combined dietary intervention (beetroot juice and folate), Group 2: Single dietary intervention (beetroot juice and placebo capsule), and Group 3: Control group (placebo beetroot juice and placebo capsule). The primary outcome of the trial was to evaluate the feasibility of the study in a low-income setting. Trial assessments included resting clinic and ambulatory 24-hr blood pressure measurements, lifestyle and dietary questionnaires and collection of biological samples. Our cohort included 8 (16.7%) males and 40 (83.3%) females with mean age 60.7 years (SD 6.5). The mean (SD) BMI, clinic systolic blood pressure and ambulatory systolic blood pressure at baseline were 27.6 kg/m2 (5.4), 151.0 (19.4), and 140.4 (15.0) mmHg, respectively. Eight (16.7%) participants were classified as pre-hypertensive, 20 (41.7%) as stage-1 hypertensive, and 20 (41.7%) as stage-2 hypertensive. Overall, the results support the feasibility of a study of this nature within a hypertensive African population. Trial registration number: ISRCTN67978523.


Publication metadata

Author(s): Kandhari N, Prabhakar M, Mmbaga BT, Rogathi J, Temu G, Gray WK, Paddick S-M, Walker R, Siervo M

Publication type: Article

Publication status: Published

Journal: Contemporary Clinical Trials Communications

Year: 2019

Volume: 16

Print publication date: 01/12/2019

Online publication date: 15/10/2019

Acceptance date: 11/10/2019

Date deposited: 11/11/2019

ISSN (electronic): 2451-8654

Publisher: Elsevier

URL: https://doi.org/10.1016/j.conctc.2019.100472

DOI: 10.1016/j.conctc.2019.100472


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