British Journal of Nutrition

Human and Clinical Nutrition

The whey fermentation product malleable protein matrix decreases TAG concentrations in patients with the metabolic syndrome: a randomised placebo-controlled trial

Ioanna Gouni-Bertholda1 c1, Dominik M. Schultea1, Wilhelm Kronea1, Jean-François Lapointea2, Pierre Lemieuxa2, Hans-Georg Predela3 and Heiner K. Bertholda4a5

a1 Center of Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Kerpener Street 62, 50937 Cologne, Germany

a2 Technologie Biolactis, Inc., Laval, QC, Canada H7V 5B7

a3 German Sport University Cologne, Cologne, Germany

a4 Lipid Clinic at the Interdisciplinary Metabolism Center, Charité University Medicine Berlin, Virchow Clinic Campus, Berlin, Germany

a5 Evangelical Geriatrics Center Berlin (EGZB), Charité Research Group on Geriatrics, Berlin, Germany

Abstract

Animal and human studies suggest that a malleable protein matrix (MPM) from whey decreases plasma lipid concentrations and may positively influence other components of the metabolic syndrome such as glucose metabolism and blood pressure (BP). The primary objective of this double-blind, multi-centre trial was to investigate the effects of a low-fat yoghurt supplemented with whey MPM on fasting TAG concentrations in patients with the metabolic syndrome. A total of 197 patients were randomised to receive MPM or a matching placebo yoghurt identical in protein content (15 g/d). Patients were treated during 3 months with two daily servings of 150 g yoghurt each to compare changes from baseline in efficacy variables. MPM treatment resulted in a significantly larger reduction of TAG concentrations in comparison to placebo (relative change − 16 %, P = 0·004). The difference was even more pronounced in subjects with elevated fasting TAG ( ≥ 200 mg/dl) at baseline ( − 18 %, P = 0·005). The relative treatment difference in fasting plasma glucose was − 7·1 mg/dl (P = 0·089). This effect was also more pronounced in subjects with impaired fasting glucose at baseline ( − 11 mg/dl, P = 0·03). In patients with hypertension, the relative treatment difference in systolic BP reached − 5·9 mmHg (P = 0·054). The relative treatment difference in body weight was − 1·7 kg (P = 0·015). The most common adverse events were gastrointestinal in nature. Conclusions from the present study are that consumption of a low-fat yoghurt supplemented with whey MPM twice a day over 3 months significantly reduces fasting TAG concentrations in patients with the metabolic syndrome and improves multiple other cardiovascular risk factors.

(Received March 08 2011)

(Revised July 27 2011)

(Accepted August 01 2011)

(Online publication October 14 2011)

Correspondence:

c1 Corresponding author: Professor I. Gouni-Berthold, fax +49 221 478 86937, email ioanna.berthold@uni-koeln.de

Footnotes

Abbreviations: AE, adverse event; BP, blood pressure; DBP, diastolic blood pressure; f, female; FAS, full analysis set; FPG, fasting plasma glucose; HDL-C, HDL-cholesterol; HOMA, homeostasis model assessment; INS, insulin; ITT, intention-to-treat; LDL-C, LDL-cholesterol; m, male; MPM, malleable protein matrix; PP, per-protocol; SAE, serious adverse event; SBP, systolic blood pressure; T2DM, type 2 diabetes mellitus; TC, total cholesterol

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