Studies structure
The brand new National Center, Lung and you will Blood Institute (NHLBI) Biologic Sample and you may Data Repository Pointers Matching Cardiovascular system (BioLINCC) considering usage of the latest Dashboard–Salt demo research towards the urinary Na + , K + , and you can SBP thinking out of study participants. The style of the Dashboard–Sodium demo might have been demonstrated in more detail before . Inside temporary, and you can summarized when you look at the Fig. step one, a beneficial randomized control trial is actually presented into the 412 those who was basically suit grownups old 22 many years otherwise earlier who have been maybe not bringing people antihypertensive pills having a great SBP from 120–159 mmHg and you may diastolic hypertension (DBP) from 80–95 mmHg (diversity regular so you can Phase step 1 blood pressure level). After the an evaluating phase and you may a two-day run-in period having a processing eating plan, representing an everyday American eating plan, analysis people was basically randomized toward weight loss input months to help you good manage diet otherwise a dashboard eating plan which is abundant with fruits, make, low-weight dairy food and this increases K + intake to
120 mmol/big date (cuatro.eight grams K + /day). For every single dieting case try further randomized for the a crossover structure resulting inside for each new member getting its respective diet plan (manage otherwise Dash) which has low (LS; 50 mmol Na + /day-max every day Na + intake), intermediate (IS; a hundred mmol Na + /day-upper maximum from everyday Na + consumption pointers), otherwise high (HS; 150 mmol Na + /day-current mediocre each day You Na + intake) Na + posts, having thirty days per within the a great randomized purchase. Multiple procedures, and bonuses (age.grams., bucks and you may low-cash awards, private reassurance), daily record, and you will systematic employees monitoring ensured fat loss compliance .
Twenty-four-time ambulatory blood pressure levels recordings was in fact taken throughout one or two evaluating symptoms and you will in the last nine days of per weight loss input several months. The knowledge utilized for investigation portray the common eliminated SBP measured more per specified several months. 24-h urine products had been acquired during the evaluation and you will during the last few days of every losing weight intervention serving period. Prior to sites at ?80 °C urine samples was mixed to be certain a consistent decide to try and aliquoted within the 5 ml quantities with 2 falls out-of 6 N HCl added each aliquot.
In today’s analysis, we used testing values to possess SBP and you will urinary lab parameters of 222 SS and you can 186 of SR users to test Na + hi5 and you can K + relations having baseline blood pressure level. So you can evaluate prospective relationships regarding urinary Na + and you can K + that have SBP responding so you can transform about HS into the LS Dash diet, we analyzed SBP only, and you can urinary parameter viewpoints off professionals of which the around three urine trials (Evaluation, LS, and HS) was indeed readily available for analysis. It led to the analysis regarding 71 SS and 119 SR users.
Study research
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.
