Novel low-sodium salt formulations combined with Chinese modified DASH diet for reducing blood pressure in patients with hypertension and type 2 diabetes: a clinical trial
Ziyan Zhang, Xiaomeng Zhou, Ying Mei, Xiaoqing Bu, Jie Tang, Tao Gong, Guowei Liu, Shuwen Cai, Yanni Ren, Lihong Mu
Abstract
Background In this study, we aimed to explore the antihypertensive effect of 23 and 52% concentrations of low-sodium salt combined with the Chinese Modified Dietary Approaches to Stop Hypertension (CM-DASH) diet in patients with hypertension and type 2 diabetes. Methods We conducted a randomized controlled single-blind trial with a semi-open design. One hundred and thirty-two participants were randomly assigned into Group A (control group), Group B (52% low-sodium salt group), Group C (23% low-sodium salt group), and Group D (meal pack group) for 8 weeks of dietary intervention. All participants were followed weekly to collect data on blood pressure, salt use, and adverse events. Blood and 24-h urine samples were analyzed at baseline, 4 weeks, and the end of the intervention. Results At the end of the intervention, the mean blood pressure decreased significantly by 10.81/5.03 mmHg, 14.32/6.32 mmHg, 14.20/6.59 mmHg, and 19.06/7.82 mmHg in Groups A–D, respectively, compared with baseline ( p < 0.001). Comparison between groups showed that the systolic blood pressure was lower in Groups C and D than in Groups A (−6.54 mmHg, −8.70 mmHg, p < 0.05) and B (−6.60 mmHg, −8.76 mmHg, p < 0.05), and the diastolic blood pressure was lower in Group D than in Group A (−5.17 mmHg, p = 0.006). The 24-h urinary Na + and Na + /K + values were significantly decreased in participants using low-sodium salt ( p < 0.001). No serious adverse events occurred during the trial. Conclusion Our preliminary results suggest that 23 and 52% concentrations of low-sodium salt combined with the CM-DASH diet can effectively reduce sodium intake and increase potassium intake in patients with hypertension and type 2 diabetes mellitus, thus achieving “salt reduction” and attaining standard, smooth, comprehensive management of patients with hypertension and type 2 diabetes. Clinical trial registration http://www.chictr.org.cn/ , ChiCTR2000029017.