Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials.
Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials.
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DOI：
10.3389/fnut.2022.886597
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发表时间：
2022
影响因子：
5
通讯作者：
Heiss, Christian
中科院分区：
文献类型：
--
作者：
Bapir, Mariam;Campagnolo, Paola;Rodriguez-Mateos, Ana;Skene, Simon S.;Heiss, Christian
对照临床干预研究表明，可可黄烷醇(CF)可以降低健康人体的血压和动脉僵硬，尽管已有报道称，在不同试验中，其效果大小存在很大差异。在这项研究中，我们通过一系列n-of-1试验在血压正常、携带个人设备的健康自由生活个体中评估了日常生活中对CF反应的个体内和个体间的变异性。总共有11名健康的年轻人参加了一项重复交叉、随机对照、n-of-1的双盲试验。在连续8天中，每个志愿者在两个随机序列(CF-P-CF-P或P-CF-P-CF)中的一个中交替天服用6粒CF胶囊(862 Mg CF)，连续4天服用6粒相匹配的安慰剂胶囊(P，0 mg CF/天)。每一天，在基线测量后，早上与早餐同时服用胶囊。每个受试者都配备了一个上臂血压监测器和一个测量脉搏波速度(PWV)的指夹。参与者在白天的12小时内至少每小时测量一次血压、心率和脉搏血流量。在前2天，在监督下进行测量以提供培训。总体混合模型分析显示，补肾益气胶囊显著降低12h收缩压和脉搏血流量，−分别为1.40±0.3mHg和−0.11±0.03m/S。服药后3h达高峰(1.5hSBP：−4.9±2.2 mm Hg，PWV0.32±0.17m/S)，8h后再次见效。在回答中发现了很大的个体间差异[组内相关系数(ICC)：0.41，0.41]。在分析单个个体的数据集时，个体的反应也有相当大的日间差异，不同受试者之间的差异很大(ICC：0-0.30，0-0.22，0-0.45)。无论是受试者之间还是受试者内部，效应大小都与基线血压值呈负相关。数据证实，可可在正常范围内升高时，可以降低日常生活中的血压和动脉僵硬。个体间和个体内反应的巨大差异要求采取更个性化的营养干预策略。
Controlled clinical intervention studies have demonstrated that cocoa flavanols (CF) can decrease blood pressure and arterial stiffness in healthy humans, although a large variability in the effect size across trials has been reported. In this study, we evaluated the intra- and inter-individual variability of responses to CF in everyday life using a series of n-of-1 trials in healthy free-living individuals with normal blood pressure carrying personal devices. In total, eleven healthy young humans participated in a repeated crossover randomized controlled double-blind n-of-1 trial. On 8 consecutive days, each volunteer consumed on alternating days 6 CF capsules (862 mg CF) on 4 days and 6 matched placebo capsules (P, 0 mg CF/day) on another 4 days in one of the two randomized sequences (CF-P-CF-P-CF-P-CF-P or P-CF-P-CF-P-CF-P-CF). On each day, the capsules were taken at the same time in the morning with breakfast after baseline measurements. Each subject was provided with an upper arm blood pressure monitor and a finger clip that measures pulse wave velocity (PWV). Measurements of blood pressure, heart rate, and PWV were taken at least hourly over 12 h during the day by the participants. On the first 2 days, measurements were performed under supervision to provide training. The overall mixed model analysis showed that CF significantly decreased 12-h systolic blood pressure and PWV by −1.4 ± 0.3 mmHg and −0.11 ± 0.03 m/s, respectively. Peak effects were observed within the first 3 h (1.5 h SBP: −4.9 ± 2.2 mmHg, PWV: −0.32 ± 0.17 m/s) and again after 8 h post-ingestion. Large inter-individual variation in responses was found [intra-cluster correlation coefficients (ICC): 0.41, 0.41]. When analyzing single individuals’ datasets, there was also considerable between-day variation in individual responses that varied greatly between subjects (ICC: 0–0.30, 0–0.22, 0–0.45). Effect sizes inversely correlated with baseline blood pressure values both between- and within-subjects. The data confirm that cocoa can decrease blood pressure and arterial stiffness in everyday life when elevated within the normal range. The large inter- and intra-individual variation in responses calls for more personalized nutritional intervention strategies.
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影响因子：
4.6
作者：
Ottaviani JI;Borges G;Momma TY;Spencer JP;Keen CL;Crozier A;Schroeter H
通讯作者：
Schroeter H
影响因子：
5.2
作者：
通讯作者：
--
影响因子：
1.6
作者：
Bussy U;Hewitt G;Olanrewaju Y;May BR;Anderson N;Ottaviani JI;Kwik-Uribe C
通讯作者：
Kwik-Uribe C
影响因子：
5.7
作者：
Canoy, Dexter;Copland, Emma;Nazarzadeh, Milad;Ramakrishnan, Rema;Pinho-Gomes, Ana-Catarina;Salam, Abdul;Dwyer, Jamie P.;Farzadfar, Farshad;Sundstrom, Johan;Woodward, Mark;Davis, Barry R.;Rahimi, Kazem
通讯作者：
Rahimi, Kazem
影响因子：
6.1
作者：
Bussy, Ugo;Ottaviani, Javier, I;Kwik-Uribe, Catherine
通讯作者：
Kwik-Uribe, Catherine