Safety and efficacy of cocoa flavanol intake in healthy adults: A randomized, controlled, double-masked trial1,2

Javier I. Ottaviani, Marion Balz, Jennifer Kimball, Jodi L. Ensunsa, Reedmond Fong, Tony Y. Momma, Catherine Kwik-Uribe, Hagen Schroeter, Carl L Keen

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background: Evidence from dietary intervention studies shows that the intake of flavanols and procyanidins can be beneficial for cardiovascular health. Nevertheless, there is a clear need for advancing our understanding with regard to safe amounts of intake for these bioactives. Objective: The aim was to investigate in healthy adults the effects of cocoa flavanol (CF) intake amount and intake duration on blood pressure, platelet function, metabolic variables, and potential adverse events (AEs). Design: This investigation consisted of 2 parts. Part 1 was an openlabel, intake-amount escalation study, in which 34 healthy adults (aged 35-55 y) consumed escalating amounts of CFs, ranging from 1000 to 2000 mg/d over 6 wk. Primary outcomes were blood pressure and platelet function, select metabolic variables, and the occurrence and severity of AEs. Secondary outcomes included plasma concentrations of CF-derived metabolites and methylxanthines. On the basis of the outcomes of study part 1, and assessing the same outcome measures, part 2 of this investigation was a controlled, randomized, double-masked, 2-parallel-arm dietary intervention study in which healthy participants (aged 35-55 y) were asked to consume for 12 consecutive weeks up to 2000 mg CFs/d (n = 46) or a CF-free control (n = 28). Results: Daily intake of up to 2000 mg CFs/d for 12 wk was not associated with significant changes in blood pressure or platelet function compared with CF-free controls in normotensive, healthy individuals who exhibited a very low risk of cardiovascular disease. There were no clinically relevant changes in the metabolic variables assessed in either of the groups. AEs reported were classified as mild in severity and did not significantly differ between study arms. Conclusion: The consumption of CFs in amounts up to 2000 mg/d for 12 wk was well tolerated in healthy men and women. This trial was registered at clinicaltrials.gov as NCT02447770 (part 1) and NCT02447783 (part 2).

Original languageEnglish (US)
Pages (from-to)1425-1435
Number of pages11
JournalAmerican Journal of Clinical Nutrition
Volume102
Issue number6
DOIs
StatePublished - Dec 1 2015

Fingerprint

Blood Platelets
Blood Pressure
Safety
Outcome Assessment (Health Care)
Proanthocyanidins
Healthy Volunteers
Cardiovascular Diseases
Health
methylxanthine

Keywords

  • Cocoa
  • Epicatechin
  • Flavanol
  • Procyanidin
  • Safety

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

Cite this

Ottaviani, J. I., Balz, M., Kimball, J., Ensunsa, J. L., Fong, R., Momma, T. Y., ... Keen, C. L. (2015). Safety and efficacy of cocoa flavanol intake in healthy adults: A randomized, controlled, double-masked trial1,2. American Journal of Clinical Nutrition, 102(6), 1425-1435. https://doi.org/10.3945/ajcn.115.116178

Safety and efficacy of cocoa flavanol intake in healthy adults : A randomized, controlled, double-masked trial1,2. / Ottaviani, Javier I.; Balz, Marion; Kimball, Jennifer; Ensunsa, Jodi L.; Fong, Reedmond; Momma, Tony Y.; Kwik-Uribe, Catherine; Schroeter, Hagen; Keen, Carl L.

In: American Journal of Clinical Nutrition, Vol. 102, No. 6, 01.12.2015, p. 1425-1435.

Research output: Contribution to journalArticle

Ottaviani, JI, Balz, M, Kimball, J, Ensunsa, JL, Fong, R, Momma, TY, Kwik-Uribe, C, Schroeter, H & Keen, CL 2015, 'Safety and efficacy of cocoa flavanol intake in healthy adults: A randomized, controlled, double-masked trial1,2', American Journal of Clinical Nutrition, vol. 102, no. 6, pp. 1425-1435. https://doi.org/10.3945/ajcn.115.116178
Ottaviani, Javier I. ; Balz, Marion ; Kimball, Jennifer ; Ensunsa, Jodi L. ; Fong, Reedmond ; Momma, Tony Y. ; Kwik-Uribe, Catherine ; Schroeter, Hagen ; Keen, Carl L. / Safety and efficacy of cocoa flavanol intake in healthy adults : A randomized, controlled, double-masked trial1,2. In: American Journal of Clinical Nutrition. 2015 ; Vol. 102, No. 6. pp. 1425-1435.
@article{69e373e0bf1d4f868f1b14b4b9b104dd,
title = "Safety and efficacy of cocoa flavanol intake in healthy adults: A randomized, controlled, double-masked trial1,2",
abstract = "Background: Evidence from dietary intervention studies shows that the intake of flavanols and procyanidins can be beneficial for cardiovascular health. Nevertheless, there is a clear need for advancing our understanding with regard to safe amounts of intake for these bioactives. Objective: The aim was to investigate in healthy adults the effects of cocoa flavanol (CF) intake amount and intake duration on blood pressure, platelet function, metabolic variables, and potential adverse events (AEs). Design: This investigation consisted of 2 parts. Part 1 was an openlabel, intake-amount escalation study, in which 34 healthy adults (aged 35-55 y) consumed escalating amounts of CFs, ranging from 1000 to 2000 mg/d over 6 wk. Primary outcomes were blood pressure and platelet function, select metabolic variables, and the occurrence and severity of AEs. Secondary outcomes included plasma concentrations of CF-derived metabolites and methylxanthines. On the basis of the outcomes of study part 1, and assessing the same outcome measures, part 2 of this investigation was a controlled, randomized, double-masked, 2-parallel-arm dietary intervention study in which healthy participants (aged 35-55 y) were asked to consume for 12 consecutive weeks up to 2000 mg CFs/d (n = 46) or a CF-free control (n = 28). Results: Daily intake of up to 2000 mg CFs/d for 12 wk was not associated with significant changes in blood pressure or platelet function compared with CF-free controls in normotensive, healthy individuals who exhibited a very low risk of cardiovascular disease. There were no clinically relevant changes in the metabolic variables assessed in either of the groups. AEs reported were classified as mild in severity and did not significantly differ between study arms. Conclusion: The consumption of CFs in amounts up to 2000 mg/d for 12 wk was well tolerated in healthy men and women. This trial was registered at clinicaltrials.gov as NCT02447770 (part 1) and NCT02447783 (part 2).",
keywords = "Cocoa, Epicatechin, Flavanol, Procyanidin, Safety",
author = "Ottaviani, {Javier I.} and Marion Balz and Jennifer Kimball and Ensunsa, {Jodi L.} and Reedmond Fong and Momma, {Tony Y.} and Catherine Kwik-Uribe and Hagen Schroeter and Keen, {Carl L}",
year = "2015",
month = "12",
day = "1",
doi = "10.3945/ajcn.115.116178",
language = "English (US)",
volume = "102",
pages = "1425--1435",
journal = "American Journal of Clinical Nutrition",
issn = "0002-9165",
publisher = "American Society for Nutrition",
number = "6",

}

TY - JOUR

T1 - Safety and efficacy of cocoa flavanol intake in healthy adults

T2 - A randomized, controlled, double-masked trial1,2

AU - Ottaviani, Javier I.

AU - Balz, Marion

AU - Kimball, Jennifer

AU - Ensunsa, Jodi L.

AU - Fong, Reedmond

AU - Momma, Tony Y.

AU - Kwik-Uribe, Catherine

AU - Schroeter, Hagen

AU - Keen, Carl L

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Background: Evidence from dietary intervention studies shows that the intake of flavanols and procyanidins can be beneficial for cardiovascular health. Nevertheless, there is a clear need for advancing our understanding with regard to safe amounts of intake for these bioactives. Objective: The aim was to investigate in healthy adults the effects of cocoa flavanol (CF) intake amount and intake duration on blood pressure, platelet function, metabolic variables, and potential adverse events (AEs). Design: This investigation consisted of 2 parts. Part 1 was an openlabel, intake-amount escalation study, in which 34 healthy adults (aged 35-55 y) consumed escalating amounts of CFs, ranging from 1000 to 2000 mg/d over 6 wk. Primary outcomes were blood pressure and platelet function, select metabolic variables, and the occurrence and severity of AEs. Secondary outcomes included plasma concentrations of CF-derived metabolites and methylxanthines. On the basis of the outcomes of study part 1, and assessing the same outcome measures, part 2 of this investigation was a controlled, randomized, double-masked, 2-parallel-arm dietary intervention study in which healthy participants (aged 35-55 y) were asked to consume for 12 consecutive weeks up to 2000 mg CFs/d (n = 46) or a CF-free control (n = 28). Results: Daily intake of up to 2000 mg CFs/d for 12 wk was not associated with significant changes in blood pressure or platelet function compared with CF-free controls in normotensive, healthy individuals who exhibited a very low risk of cardiovascular disease. There were no clinically relevant changes in the metabolic variables assessed in either of the groups. AEs reported were classified as mild in severity and did not significantly differ between study arms. Conclusion: The consumption of CFs in amounts up to 2000 mg/d for 12 wk was well tolerated in healthy men and women. This trial was registered at clinicaltrials.gov as NCT02447770 (part 1) and NCT02447783 (part 2).

AB - Background: Evidence from dietary intervention studies shows that the intake of flavanols and procyanidins can be beneficial for cardiovascular health. Nevertheless, there is a clear need for advancing our understanding with regard to safe amounts of intake for these bioactives. Objective: The aim was to investigate in healthy adults the effects of cocoa flavanol (CF) intake amount and intake duration on blood pressure, platelet function, metabolic variables, and potential adverse events (AEs). Design: This investigation consisted of 2 parts. Part 1 was an openlabel, intake-amount escalation study, in which 34 healthy adults (aged 35-55 y) consumed escalating amounts of CFs, ranging from 1000 to 2000 mg/d over 6 wk. Primary outcomes were blood pressure and platelet function, select metabolic variables, and the occurrence and severity of AEs. Secondary outcomes included plasma concentrations of CF-derived metabolites and methylxanthines. On the basis of the outcomes of study part 1, and assessing the same outcome measures, part 2 of this investigation was a controlled, randomized, double-masked, 2-parallel-arm dietary intervention study in which healthy participants (aged 35-55 y) were asked to consume for 12 consecutive weeks up to 2000 mg CFs/d (n = 46) or a CF-free control (n = 28). Results: Daily intake of up to 2000 mg CFs/d for 12 wk was not associated with significant changes in blood pressure or platelet function compared with CF-free controls in normotensive, healthy individuals who exhibited a very low risk of cardiovascular disease. There were no clinically relevant changes in the metabolic variables assessed in either of the groups. AEs reported were classified as mild in severity and did not significantly differ between study arms. Conclusion: The consumption of CFs in amounts up to 2000 mg/d for 12 wk was well tolerated in healthy men and women. This trial was registered at clinicaltrials.gov as NCT02447770 (part 1) and NCT02447783 (part 2).

KW - Cocoa

KW - Epicatechin

KW - Flavanol

KW - Procyanidin

KW - Safety

UR - http://www.scopus.com/inward/record.url?scp=84948807551&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84948807551&partnerID=8YFLogxK

U2 - 10.3945/ajcn.115.116178

DO - 10.3945/ajcn.115.116178

M3 - Article

C2 - 26537937

AN - SCOPUS:84948807551

VL - 102

SP - 1425

EP - 1435

JO - American Journal of Clinical Nutrition

JF - American Journal of Clinical Nutrition

SN - 0002-9165

IS - 6

ER -