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Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients on Hemodialysis: A Double-Blind, Randomized, Placebo-Controlled Trial.
Clin J Am Soc Nephrol 2016; 11(1):108-18CJ

Abstract

BACKGROUND AND OBJECTIVES

Hemodialysis (HD) per se entails vascular dysfunction in patients with ESRD. Endothelial dysfunction is a key step in atherosclerosis and is characterized by impaired flow-mediated dilation (FMD). Interventional studies have shown that cocoa flavanol (CF)-rich supplements improve vascular function. Aim of this study was to investigate the effect of flavanol-rich bioactive food ingredients on acute and chronic HD-induced vascular dysfunction in ESRD.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS

We conducted a randomized, double-blind, placebo-controlled trial from 2012 to 2013. Fifty-seven participants were enrolled, ingested CF-rich beverages (900 mg CF per study day), and were compared with those ingesting CF-free placebo. This included (1) a baseline cross-over acute study to determine safety and efficacy of CF and (2) a subsequent chronic parallel group study with a 30-day follow-up period to study effects of CF on HD-mediated vascular dysfunction entailing (3) an acute substudy during HD in flavanol-naive patients and (4) an acute on chronic study during HD. Primary and secondary outcome measures included changes in FMD and hemodynamics.

RESULTS

CF ingestion was well tolerated. Acute ingestion improved FMD by 53% (3.2±0.6% to 4.8±0.9% versus placebo, 3.2±0.7% to 3.3±0.8%; P<0.001), with no effects on BP or heart rate. A 30-day ingestion of CF led to an increase in baseline FMD by 18% (3.4±0.9% to 3.9±0.8% versus placebo, 3.5±0.7% to 3.5±0.7%; P<0.001), with reduced diastolic BP (73±12 to 69±11 mmHg versus placebo, 70±11 to 73±13 mmHg; P=0.03) and increased heart rate (70±12 to 74±13 bpm versus placebo, 75±15 to 74±13 bpm; P=0.01). No effects were observed for placebo. Acute ingestion of CF during HD alleviated HD-induced vascular dysfunction (3.4±0.9% to 2.7±0.6% versus placebo, 3.5±0.7% to 2.0±0.6%; P<0.001). This effect was sustained throughout the study (acute on chronic, 3.9±0.9% to 3.0±0.7% versus placebo, 3.5±0.7% to 2.2±0.6; P=0.01).

CONCLUSIONS

Dietary CF ingestion mitigates acute HD-induced and chronic endothelial dysfunction in patients with ESRD and thus, improves vascular function in this high-risk population. Larger clinical trials are warranted to test whether this translates into an improved cardiovascular prognosis in patients with ESRD.

Authors+Show Affiliations

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany; Tienush.Rassaf@uk-essen.de.Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany;Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany;Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany;DaVita Renal Center Düsseldorf, Düsseldorf, Germany;DaVita Renal Center Düsseldorf, Düsseldorf, Germany;Department of Nephrology, Rheinish-Westphalian Technical High School, University of Aachen, Aachen, Germany; and.DaVita Renal Center Düsseldorf, Düsseldorf, Germany;Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany; Medical Faculty, Cardiovascular Research Institute Düsseldorf (CARID), University Hospital Düsseldorf, Düsseldorf, Germany.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26681132

Citation

Rassaf, Tienush, et al. "Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients On Hemodialysis: a Double-Blind, Randomized, Placebo-Controlled Trial." Clinical Journal of the American Society of Nephrology : CJASN, vol. 11, no. 1, 2016, pp. 108-18.
Rassaf T, Rammos C, Hendgen-Cotta UB, et al. Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients on Hemodialysis: A Double-Blind, Randomized, Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2016;11(1):108-18.
Rassaf, T., Rammos, C., Hendgen-Cotta, U. B., Heiss, C., Kleophas, W., Dellanna, F., ... Kelm, M. (2016). Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients on Hemodialysis: A Double-Blind, Randomized, Placebo-Controlled Trial. Clinical Journal of the American Society of Nephrology : CJASN, 11(1), pp. 108-18. doi:10.2215/CJN.05560515.
Rassaf T, et al. Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients On Hemodialysis: a Double-Blind, Randomized, Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2016 Jan 7;11(1):108-18. PubMed PMID: 26681132.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vasculoprotective Effects of Dietary Cocoa Flavanols in Patients on Hemodialysis: A Double-Blind, Randomized, Placebo-Controlled Trial. AU - Rassaf,Tienush, AU - Rammos,Christos, AU - Hendgen-Cotta,Ulrike B, AU - Heiss,Christian, AU - Kleophas,Werner, AU - Dellanna,Frank, AU - Floege,Jürgen, AU - Hetzel,Gerd R, AU - Kelm,Malte, Y1 - 2015/12/17/ PY - 2015/05/20/received PY - 2015/09/15/accepted PY - 2015/12/19/entrez PY - 2015/12/19/pubmed PY - 2016/11/1/medline KW - blood pressure KW - cocoa-flavanols KW - double-blind method KW - endothelial function KW - heart rate KW - hemodialysis KW - hemodynamics KW - humans KW - kidney failure, chronic KW - nutrition KW - vascular functions SP - 108 EP - 18 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 11 IS - 1 N2 - BACKGROUND AND OBJECTIVES: Hemodialysis (HD) per se entails vascular dysfunction in patients with ESRD. Endothelial dysfunction is a key step in atherosclerosis and is characterized by impaired flow-mediated dilation (FMD). Interventional studies have shown that cocoa flavanol (CF)-rich supplements improve vascular function. Aim of this study was to investigate the effect of flavanol-rich bioactive food ingredients on acute and chronic HD-induced vascular dysfunction in ESRD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a randomized, double-blind, placebo-controlled trial from 2012 to 2013. Fifty-seven participants were enrolled, ingested CF-rich beverages (900 mg CF per study day), and were compared with those ingesting CF-free placebo. This included (1) a baseline cross-over acute study to determine safety and efficacy of CF and (2) a subsequent chronic parallel group study with a 30-day follow-up period to study effects of CF on HD-mediated vascular dysfunction entailing (3) an acute substudy during HD in flavanol-naive patients and (4) an acute on chronic study during HD. Primary and secondary outcome measures included changes in FMD and hemodynamics. RESULTS: CF ingestion was well tolerated. Acute ingestion improved FMD by 53% (3.2±0.6% to 4.8±0.9% versus placebo, 3.2±0.7% to 3.3±0.8%; P<0.001), with no effects on BP or heart rate. A 30-day ingestion of CF led to an increase in baseline FMD by 18% (3.4±0.9% to 3.9±0.8% versus placebo, 3.5±0.7% to 3.5±0.7%; P<0.001), with reduced diastolic BP (73±12 to 69±11 mmHg versus placebo, 70±11 to 73±13 mmHg; P=0.03) and increased heart rate (70±12 to 74±13 bpm versus placebo, 75±15 to 74±13 bpm; P=0.01). No effects were observed for placebo. Acute ingestion of CF during HD alleviated HD-induced vascular dysfunction (3.4±0.9% to 2.7±0.6% versus placebo, 3.5±0.7% to 2.0±0.6%; P<0.001). This effect was sustained throughout the study (acute on chronic, 3.9±0.9% to 3.0±0.7% versus placebo, 3.5±0.7% to 2.2±0.6; P=0.01). CONCLUSIONS: Dietary CF ingestion mitigates acute HD-induced and chronic endothelial dysfunction in patients with ESRD and thus, improves vascular function in this high-risk population. Larger clinical trials are warranted to test whether this translates into an improved cardiovascular prognosis in patients with ESRD. SN - 1555-905X UR - https://www.unboundmedicine.com/medline/citation/26681132/Vasculoprotective_Effects_of_Dietary_Cocoa_Flavanols_in_Patients_on_Hemodialysis:_A_Double_Blind_Randomized_Placebo_Controlled_Trial_ L2 - http://cjasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=26681132 DB - PRIME DP - Unbound Medicine ER -