BACKGROUND:Healthy diet is essential for cardiovascular disease risk management, but its effects among Chinese patients, whose diets differ from Western diets, remain largely unknown. METHODS:In this multicenter, patient- and outcome assessor-blind, randomized controlled feeding trial, 265 Chinese adults with baseline systolic blood pressure 130 to 159 mmHg were randomly assigned into Chinese heart-healthy (CHH) diet or usual diet for a 28-d intervention after a 7-d run-in period on usual diet. Blood lipids and glucose were measured from overnight fasting blood samples before and after the intervention. Ten-year cardiovascular disease risk was estimated using models previously developed and validated in Chinese. The changes in secondary outcomes of serum total cholesterol (TC), blood glucose, and 10-y cardiovascular disease risk over the intervention period were compared between intervention groups, adjusting for center, among participants with baseline and follow-up blood samples available. Sensitivity analyses were done with further adjustment for baseline values and covariables; missing data imputed; and among per-protocol population. RESULTS:Among 256 eligible participants (130 on CHH diet, 126 on control diet), 42% had hypercholesterolemia and 15% had diabetes at baseline. In the control group, TC and 10-y cardiovascular disease risk decreased after the intervention by 0.16 mmol/L and 0.91%, respectively, but blood glucose increased by 0.25 mmol/L. Compared with usual diet, the CHH diet lowered TC (-0.14 mmol/L, P = 0.017) and 10-y cardiovascular disease risk (-1.24%, P = 0.001) further. No effect on blood glucose was found. All sensitivity analyses confirmed the results on TC and 10-y cardiovascular disease risk, and analysis with multiple variables adjusted showed a borderline significant effect on blood glucose (-0.17 mmol/L, P = 0.051). The differences in intake of nutrients and food groups between intervention groups explained the results. CONCLUSIONS:The CHH diet reduced TC and 10-y cardiovascular disease risk and was likely to reduce blood glucose among Chinese adults with mild hypertension. Further studies with longer terms are warranted. This trial was registered at clinicaltrials.gov as NCT03882645.
目的 通过前瞻性、随机单盲平行对照临床试验,评价心脏健康膳食干预对心血管疾病高风险人群的血压、氧化应激指标的影响.方法 在上海地区招募基线收缩压为130~159 mmHg的心血管疾病高风险受试者71例,经过7 d相同餐食洗脱后,所有受试者随机分入对照组与干预组,用对照膳食或心脏健康膳食进行28 d全程膳食管理干预.干预组的心脏健康膳食特点为增加全谷物摄入量,保证新鲜蔬菜和水果充足摄入,动物性食物多鱼虾少猪肉,增加奶制品摄入,烹调清淡少油少盐,使用高钾低钠盐.对照组给予符合上海地区饮食习惯的常规膳食.结果 干预组心脏健康膳食的大豆及坚果类、鱼虾类和蔬菜类供给量高,而畜禽肉类、盐(5.21±0.04)vs(10.75±0.10)g、食用油(20.96±0.13)vs(37.46±0.98)g供给量低于对照组(P<0.05).营养素分析显示,试验期间干预组受试者平均摄入的蛋白质、碳水化合物、膳食纤维、钾、钙和镁摄入量高于对照组,而脂肪、胆固醇和钠摄入量低于对照组(P<0.05).干预结果显示,干预组受试者收缩压下降(16.9±1.4)mmHg,舒张压下降(7.3±1.1)mmHg、与对照组相比平均收缩压多下降10.7 mmHg,平均舒张压较多下降3.7 mmHg,差异均有统计学意义(P<0.05).干预组受试者血清丙二醛含量降低1.35 nmol/L,谷胱甘肽和超氧化物歧化酶分别上升1.85μmol/L和13.75 U/mL,与对照组相比差异有统计学意义(P<0.05).结论 心脏健康膳食可以降低上海地区心血管疾病高风险人群的血压,同时改善其氧化应激状态.
DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials, report the details of blinding, conduct a blinding survey and calculate Jame's BI and Bang's BI. Jame's BI was 0.683 (95% CI: 0.593~0.772). The Bang's BI for the intervention group was 0.340 (95% CI: 0.199~0.481), and for the control group was 0.086 (95% CI: -0.060~0.231). The blinding of the DECIDE)-Diet was generally successful, but the intervention group may infer their group to a certain extent. Feeding trials should report the details of blinding and consider blinding assessment.
At present, it is a trend to use dietary supplements to prevent age-related cognitive impairment. This study aimed to investigate the effects of a dietary supplement enriched with micronutrients, phosphatidylserine, and docosahexaenoic acid on cognitive performance using a D-galactose (D-gal) induced aging rat model. Seven-month-old male Sprague-Dawley rats were randomly divided into five groups, including the control group, D-gal model group, and low-dose (2 g/kg body weight), medium-dose (6 g/kg body weight), and high-dose (10 g/kg body weight) dietary supplement intervention groups, which were investigated for 13 weeks. The dietary supplement intervention was found to improve cognitive performance in Morris water maze test, increase superoxidase dismutase activity, reduce malondialdehyde activity, decrease tumor necrosis factor-α and interleukin-6 concentrations, inhibit the activation of astrocytes, and elevate brain-derived neurotrophic factor protein and mRNA expression in the brains of D-gal-induced aged rats. This dietary supplement customized for the aged can be applied to the restoration of cognitive performance by enhancing antioxidant and anti-neuroinflammatory abilities, up-regulating neurotrophic factors, and inhibiting the activation of astrocytes. These results will be useful for future studies focused on implementation in humans.
Background: More than one-fifth of the world’s population consumes Chinese cuisines regularly, but no evidence-based healthy diets fitting the Chinese food culture are available for implementation. Methods: A multicenter, patient- and outcome assessor–blind, randomized feeding trial was conducted among 265 participants with 130 to 159 mm Hg baseline systolic blood pressure (SBP) for 4 major Chinese cuisines (Shangdong, Huaiyang, Cantonese, Szechuan). After a 7-day run-in period on a control diet matching the usual local diets, participants were randomized to continue with the control diet or the cuisine-based Chinese heart-healthy diet for another 28 days. The primary outcome was SBP, and secondary outcomes included diastolic blood pressure and food preference score. Linear regression models were used to estimate the intervention effects and adjustments for the center. The incremental cost per 1 mm Hg reduction in SBP was also calculated. Results: A total of 265 participants were randomized (135 on the Chinese heart-healthy diet and 130 on the control diet), with 52% women, mean age of 56.5±9.8 years, and mean SBP and diastolic blood pressure of 139.4±8.3 and 88.1±8.0 mm Hg, respectively, at baseline. The change in SBP and diastolic blood pressure from baseline to the end of the study in the control group was –5.0 (95% CI, –6.5 to –3.5) mm Hg and –2.8 (95% CI, –3.7 to –1.9) mm Hg, respectively. The net difference of change between the 2 groups in SBP and diastolic blood pressure were –10.0 (95% CI, –12.1 to –7.9) mm Hg and –3.8 (95% CI, –5.0 to –2.5) mm Hg, respectively. The effect size did not differ among cuisines ( P for interaction=0.173). The mean food preference score was 9.5 (with 10 the best preferred) at baseline, and the net change during intervention was 0.1 (95% CI, –0.1 to 0.2; P =0.558). The incremental cost-effectiveness ratio per 1 mm Hg SBP reduction was CNY 0.4 (USD 0.06) per day. No difference in the number of adverse events was found between the 2 groups ( P =0.259), and none of the adverse events was associated with the intervention. Conclusions: The Chinese heart-healthy diet is effective, palatable, and cost-effective in reducing blood pressure in Chinese adults with high blood pressure, with a clinically significant effect applicable across major Chinese cuisine cultures. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03882645.
目的 了解上海地区居民食物摄入现状与特点,为优化上海居民的膳食结构提供理论依据.方法 本研究采用滚雪球抽样方法,研究对象为上海地区18岁及以上的常住居民,以微信小程序为平台,进行了为期7d的膳食调查,并收集食物名称和照片.结果 在日常膳食中,摄入频次最高的主食是米饭(26.3%),菜肴前3位分别为蔬菜类(36.7%)、畜肉类及其制品(15.5%)和水产类(11.6%).部分食物组摄食频次在性别和年龄层间的分布存在差异,其中61岁及以上人群食用馒头类(P=0.029)和粥类主食(P=0.01)的频率均高于18 ~40岁人群;且女性食用坚果类食物的频率高于男性(P=0.002).结论 103名上海居民饮食结构特点为主食以稻米类为主,选择较为多样;菜肴中蔬菜类频次居首,动物性食物次之;餐时饮品则有早餐喝奶,正餐用汤的特点.
Background and Objectives: Notable inter-individual differences in cholesterol-lowering effects following oatmeal consumption have been previously reported. Genetic variations may among the reasons for the heterogeneous response to lipid modulations. And to determine whether SNP of cytochrome P450 family 7 subfamily A member 1 gene rs3808607 and isoforms of apolipoprotein E are associated with the inter-individual variations in cholesterol-lowering effects of oatmeal consumption, we did this study. Methods and Study Design: Data in this study were extracted from a parallel, controlled trial, in which 62 medication-naive hypercholesterolemic patients provided with staple food substitute of either 80 g/d oatmeal (n=31) or 80 g/d refined white rice (n=31) for 45 days. Fasting blood samples were collected at baseline and endpoint of the study for lipid profiling, glycemic testing, and genotyping. Results: Totally, 56 of 62 participants completed the study and were thus included. Genotype-diet interactions were observed between oatmeal consumption and SNP in the cytochrome P450 family 7 subfamily A member 1 gene rs3808607 in regulating LDL cholesterol (p=0.04); rs3808607-TT homozygotes exhibited significantly higher responsiveness to oatmeal (reduction in LDL cholesterol) than G allele carriers (GG/GT) (p=0.02). However, obvious genotype-diet interactions were not observed between oatmeal consumption and apolipoprotein E isoforms in cholesterol and glycemic modulation (p>0.05). Conclusions: SNP in cytochrome P450 family 7 subfamily A member 1 gene rs3808607 was associated with the extent of LDL cholesterol reduction following oatmeal consumption. Trials with larger sample sizes are required to confirm the findings.
Background In vitro and animal experiments reported a microbiota-regulating ability of oatmeal, however, related in vivo evidences remained limited. Thus, we conducted this study aiming to investigate the oatmeal-induced alteration of gut microbiota and its potential relationship with the improvements of lipid profiles. Methods and study design Data of anthropometric measurements and biochemical parameters were extracted from a randomized, controlled clinical trial, in which 62 hypercholesterolemic men and women (18–65 years old) were provided with either treatment of 80 g/day oatmeal or 80 g/day refined white rice for 45 days. Fasting blood samples and fecal samples were collected both at baseline and endpoint of the study for lipid profiling and microbiota 16S rRNA amplicon sequencing, respectively. Results Totally 28 participants (56 fecal samples) qualified with the new criteria and were thus included in this secondary analysis. The results of microbiota analysis showed that no significant difference was observed in the alteration of its overall α or β diversity between two groups throughout the study. Nor did any notable between-group difference was found in the relative abundance changes of microorganism at different taxonomies. However, results from linear discriminant analysis effect size in the oatmeal group indicated a significant positive response of Firmicutes phylum following oatmeal consumption. Further Procrustes analysis suggested a concordance trend between microorganism alteration and alleviation of hypercholesterolemia phenotypes throughout the study ( P = 0.05). The results of within-group comparison from Spearman’s correlation in the oatmeal group demonstrated a significant association between the enrichment of Blautia genus and the reduction of serum total cholesterol ( P < 0.05), low-density lipoprotein cholesterol ( P < 0.01), and apolipoprotein B ( P < 0.05). Conclusions Positive response of Firmicutes phylum might be a critical characteristic of oatmeal-induced alteration of microbiota, whereas, one of the underlying cholesterol-lowering mechanism of oatmeal consumption might be its microbiota-manipulating ability, in which the enrichment of Blautia genus played a potentially significant role. Current results should be taken cautiously and more studies were needed for further verification. Trial registration : ChiCTR, ChiCTR180001864. Registered 30 September 2018, http://www.chictr.org.cn/showproj.aspx?proj=31469 .