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 language | English (US) |
|---|---|
| Pages (from-to) | 1425-1435 |
| Number of pages | 11 |
| Journal | American Journal of Clinical Nutrition |
| Volume | 102 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 1 2015 |
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Keywords
- Cocoa
- Epicatechin
- Flavanol
- Procyanidin
- Safety
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Nutrition and Dietetics
Cite this
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 journal › Article
}
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 -