Research design
The fresh National Heart, Lung and you may Blood Institute (NHLBI) Biologic Sample and you will Study Repository Suggestions Matching Center (BioLINCC) offered usage of the latest Dash–Sodium demo research on the urinary Na + , K + , and SBP opinions regarding research participants. The style of the fresh new Dashboard–Sodium demo might have been revealed in more detail in the past . In the short-term, and you will summarized in the Fig. step one, a randomized handle demo try used into the 412 those who had been healthy people aged twenty-two ages otherwise earlier who have been maybe not providing one antihypertensive pills with a great SBP regarding 120–159 mmHg and you may diastolic blood pressure (DBP) of 80–95 mmHg (assortment regular to help you Phase step one blood circulation pressure). After the an assessment stage and you can a two-month run-in period that have a running eating plan, symbolizing a routine American eating plan, study professionals was randomized into the losing weight input months so you can a great manage diet plan or a dashboard eating plan which is abundant with good fresh fruit, make, low-fat dairy products and that grows K + consumption so you’re able to
120 mmol/day (cuatro.seven grams K + /day). For each losing weight case are subsequent randomized during the a crossover construction resulting in the each new member finding their particular eating plan (control or Dash) which has lowest (LS; 50 mmol Na + /day-maximum everyday Na + intake), advanced (IS; a hundred mmol Na + /day-higher restrict of each day Na + intake pointers), otherwise large (HS; 150 mmol Na + /day-current average daily All of us Na + intake) Na + posts, to own thirty days for each and every for the an effective randomized acquisition. Several steps, plus incentives (age.g., bucks and non-bucks honours, personal support), every day log, and scientific professionals overseeing made certain dietary compliance .
Twenty-four-hours ambulatory blood pressure level tracks was in fact drawn during the a couple evaluation periods and you can in the last nine days of per weight reduction input period. The information useful investigation depict the typical eliminated SBP measured more than per specified period. 24-h pee products was indeed received through the testing and you may over the past day each and every diet input giving months. Prior to stores on ?80 °C urine trials was indeed blended to make sure a good consistent take to and aliquoted from inside the 5 ml volumes that have dos drops from six N HCl extra for every aliquot.
In the current study, i used testing beliefs to have SBP and you may urinary lab details of 222 SS and you can 186 from SR people to test Na + and you can K + connections which have baseline blood circulation pressure. In order to evaluate prospective connections from urinary Na + and you will K + having SBP in reaction so you’re able to transform from the HS into the LS Dash eating plan, we reviewed SBP just, and you may urinary factor philosophy out of people where all the about three urine trials (Assessment, LS, and HS) had been readily available for investigation. It lead to the research regarding 71 SS and you may 119 SR members.
Data analysis
In the original DASH–Sodium trial, the baseline blood pressure used for analysis was the mean of value recorded during screening and the run-in period, and the blood pressure for the intervention period was the mean of the last five measurements at the end of each intervention. Baseline blood pressure and the clinical centers were represented as fixed effects, and the intervention periods were represented as random effects. The generalized estimating equation module of Stata was employed to compute power, and the residual variance estimate value and standard deviation for each estimate were provided. As has been previously reported the DASH–Sodium trial was sufficiently powered to detect changes evoked by the dietary interventions on SBP and DBP. The effects of Na + reduction within the control diet and the DASH diet were assessed using the Holm method, and the resulting P value < 0.05 was determined to be significant . All SBP and urinary Na + and K + excretion (mg/day) data obtained during the screening and run-in feeding period (referred to as baseline), and following 30-days LS and HS intake on either the control or DASH diet were provided to the authors via BioLINCC.
