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Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials

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 vari...

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Autores principales: Bapir, Mariam, Campagnolo, Paola, Rodriguez-Mateos, Ana, Skene, Simon S., Heiss, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9234529/
https://www.ncbi.nlm.nih.gov/pubmed/35769385
http://dx.doi.org/10.3389/fnut.2022.886597
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author Bapir, Mariam
Campagnolo, Paola
Rodriguez-Mateos, Ana
Skene, Simon S.
Heiss, Christian
author_facet Bapir, Mariam
Campagnolo, Paola
Rodriguez-Mateos, Ana
Skene, Simon S.
Heiss, Christian
author_sort Bapir, Mariam
collection PubMed
description 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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spelling pubmed-92345292022-06-28 Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials Bapir, Mariam Campagnolo, Paola Rodriguez-Mateos, Ana Skene, Simon S. Heiss, Christian Front Nutr Nutrition 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. Frontiers Media S.A. 2022-06-13 /pmc/articles/PMC9234529/ /pubmed/35769385 http://dx.doi.org/10.3389/fnut.2022.886597 Text en Copyright © 2022 Bapir, Campagnolo, Rodriguez-Mateos, Skene and Heiss. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Nutrition
Bapir, Mariam
Campagnolo, Paola
Rodriguez-Mateos, Ana
Skene, Simon S.
Heiss, Christian
Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title_full Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title_fullStr Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title_full_unstemmed Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title_short Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials
title_sort assessing variability in vascular response to cocoa with personal devices: a series of double-blind randomized crossover n-of-1 trials
topic Nutrition
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9234529/
https://www.ncbi.nlm.nih.gov/pubmed/35769385
http://dx.doi.org/10.3389/fnut.2022.886597
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