PMID- 26537937 OWN - NLM STAT- MEDLINE DCOM- 20160413 LR - 20230318 IS - 1938-3207 (Electronic) IS - 0002-9165 (Linking) VI - 102 IP - 6 DP - 2015 Dec TI - Safety and efficacy of cocoa flavanol intake in healthy adults: a randomized, controlled, double-masked trial. PG - 1425-35 LID - 10.3945/ajcn.115.116178 [doi] 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 open-label, 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). CI - (c) 2015 American Society for Nutrition. FAU - Ottaviani, Javier I AU - Ottaviani JI AD - Mars Inc., McLean, VA; and Departments of javier.ottaviani@mss.effem.com. FAU - Balz, Marion AU - Balz M AD - Mars Inc., McLean, VA; and Departments of. FAU - Kimball, Jennifer AU - Kimball J AD - Nutrition and. FAU - Ensunsa, Jodi L AU - Ensunsa JL AD - Nutrition and. FAU - Fong, Reedmond AU - Fong R AD - Nutrition and. FAU - Momma, Tony Y AU - Momma TY AD - Nutrition and. FAU - Kwik-Uribe, Catherine AU - Kwik-Uribe C AD - Mars Inc., McLean, VA; and Departments of. FAU - Schroeter, Hagen AU - Schroeter H AD - Mars Inc., McLean, VA; and Departments of. FAU - Keen, Carl L AU - Keen CL AD - Nutrition and Internal Medicine, University of California, Davis, Davis, CA. LA - eng SI - ClinicalTrials.gov/NCT02447770 SI - ClinicalTrials.gov/NCT02447783 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20151104 PL - United States TA - Am J Clin Nutr JT - The American journal of clinical nutrition JID - 0376027 RN - 0 (Antioxidants) RN - 0 (Biomarkers) RN - 0 (Flavonols) RN - 0 (Xanthines) SB - IM MH - Adult MH - Antioxidants/administration & dosage/adverse effects/metabolism/*therapeutic use MH - Biomarkers/blood MH - Blood Pressure MH - Cacao/*chemistry MH - California/epidemiology MH - Cardiovascular Diseases/blood/epidemiology/metabolism/*prevention & control MH - Cohort Studies MH - *Dietary Supplements/adverse effects MH - Double-Blind Method MH - Female MH - Flavonols/administration & dosage/adverse effects/metabolism/*therapeutic use MH - Humans MH - Intention to Treat Analysis MH - Lost to Follow-Up MH - Male MH - Middle Aged MH - Patient Dropouts MH - Platelet Aggregation MH - Risk Factors MH - Seeds/*chemistry MH - Xanthines/blood/metabolism OTO - NOTNLM OT - cocoa OT - epicatechin OT - flavanol OT - procyanidin OT - safety EDAT- 2015/11/06 06:00 MHDA- 2016/04/14 06:00 CRDT- 2015/11/06 06:00 PHST- 2015/06/01 00:00 [received] PHST- 2015/09/23 00:00 [accepted] PHST- 2015/11/06 06:00 [entrez] PHST- 2015/11/06 06:00 [pubmed] PHST- 2016/04/14 06:00 [medline] AID - S0002-9165(23)27216-0 [pii] AID - 10.3945/ajcn.115.116178 [doi] PST - ppublish SO - Am J Clin Nutr. 2015 Dec;102(6):1425-35. doi: 10.3945/ajcn.115.116178. Epub 2015 Nov 4.