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The DECIDE - Diet (Diet, ExerCIse and carDiovascular hEalth - China Heart Diet for People With High Cardiovascular Risk in China) is to evaluate the effects of China Heart Diet in reducing blood pressure in Chinese people with high cardiovascular risk. The study will recruit 360 adults people from 4 centers in China. All eligible participants will participate in a 1-week run-in phase in which they are fed the traditional Chinses diet. Participants who pass the run-in phase will be randomly assigned 1:1 to receive local China-Heart diet or traditional diet with the use of a central concealed randomization procedure (simple randomization), stratified by center and batch.
The intervention will last 28 days. Primary outcome will be the change in systolic blood pressure. The secondary outcomes include the differences between the two groups in the changes of diastolic blood pressure, total cholesterol, fasting blood glucose, 24-h urinary sodium, 10-year CVD risk, gut microbial gene richness, and microbiota composition.
The DECIDE - Diet (Diet, ExerCIse and carDiovascular hEalth - China Heart Diet for People With High Cardiovascular Risk in China) is a study in the DECIDE project, which includes five studies. The others are DECIDE - Exercise, DECIDE - Salt in Elderly, DECIDE - Obesity in Children, and DECIDE - Smart Living. The DECIDE - Diet study is to evaluate the effects of China Heart Diet in reducing blood pressure in Chinese adults with high cardiovascular risk. Specifically, the study aim is to test if the China Heart Diet could significantly reduce systolic blood pressure among adults with high cardiovascular risk.
The corresponding null hypothesis is the mean systolic blood pressure of participants in China Heart Diet group is equal to the mean systolic blood pressure of those in traditional diet group.
Potential participants will be evaluated for eligibility at four centers located in cities accordance with the four cuisines: Qingdao (Shandong cuisine), Shanghai (Huaiyang cuisine), Guangzhou (Cantonese cuisine), and Chengdu (Szechuan cuisine). Two screening visits will be performed to identify eligible participants. At the first visit, participants will be asked several key questions about inclusion and exclusion criteria. At the second visit, a full questionnaire and measurement will be conducted to screen eligible participants. All eligible participants will participate in a 1-week run-in phase in which they are fed the traditional Chinses diet. A participant will be excluded if failing to consume three meals for any reason. Participants who pass the run-in phase will be randomly assigned 1:1 to receive local China Heart Diet or traditional diet with the use of a central concealed randomization procedure (simple randomization), stratified by center and batch after the each baseline survey completed. At each center, participants will enter the randomization phase through 3-4 batches according to the feeding capacity of each center.
Four different recipes of China-Heart diet have been developed according to four local cuisines: Qingdao (Shandong cuisine), Shanghai (Huaiyang cuisine), Guangzhou (Cantonese cuisine), and Chengdu (Szechuan cuisine), but the four different healthy recipes share the same targets of nutrient compositions and energy intake. The control group will receive local traditional Chinese diet with the similar 4-week menus as China-Heart diet, but the targets of nutrient compositions and energy intake will be different. We will measure the actual intake of every meal for all participants during 4-week intervention to better estimate their nutrients compositions. All subjects will be advised to avoid other food during the study period, and we collect the information on them if they eat.
The baseline examination including three blood pressure measurements, one weight measurement and one 24-hr urine collection will be conducted for all participants. Fasting blood samples will be drawn for measurement of total cholesterol, fasting blood glucose, serum potassium and detect hyperkalemia. Feces samples will be collected for measurement of gut microbial gene richness, and microbiota composition.
All participants will be followed up for blood pressure and weight at 7, 14, 21 and 28 days, for gut microbial gene richness, and microbiota composition at 14 and 28 days, for serum total cholesterol, serum fasting blood glucose, serum potassium and 24-hr urine at 28 days.
Power analysis: We assume that China-Heart diet will reduce SBP by 3.0 mm Hg more than the control diet. As SBP ranges from 130 to 159, we assume the standard deviation (SD) of SBP will be 8 mm Hg according to our previous cohort studies. The trial is designed to have 90% power with a type I error rate of 5% to detect the difference and allows a maximum tolerated loss rate of 10%, 165 participants will be required per group. To ensure the power of this trial, we decide recruit a total of 360 participants from 4 centers .
Statistical analysis: All analyses will be performed on an intention-to-treat basis. The results will be presented as a number (percentage) for discrete variables and the mean ± SD or the median with interquartile range for continuous variables. The differences in variables between groups will be calculated by using a t test, Wilcoxon rank test, or chi-square test. Linear mixed models will be adopted to estimate the absolute differences between two groups in SBP and other continuous variables from baseline up to the end of trial, reported as least squared means after adjusting for center.
China Heart Diet, traditional diet
Not yet recruiting
Published on BioPortfolio: 2019-03-26T08:29:36-0400
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