The effect of monomeric and oligomeric FLAVAnols in patients with type 2 diabetes and microalbuminuria (FLAVA-trial): A double-blind randomized controlled trial

Mardin Rashid, Adrie J.M. Verhoeven, Monique T. Mulder, Reinier Timman, Behiye Ozcan, Yvonne van Beek-Nieuwland, Lei M. Chow, Roel J.J.M. van de Laar, Willem A. Dik, Eric J.G. Sijbrands, Kirsten A. Berk*

*Corresponding author for this work

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Abstract

Background & aims: Microalbuminuria is an early sign of vascular complications of type 2 diabetes and predicts cardiovascular disease and mortality. Monomeric and oligomeric flavanols (MOFs) are linked to improved vascular health. The aim of this study was to assess the effect of 3 months MOFs on albuminuria and endothelial function markers in patients with type 2 diabetes and microalbuminuria. Methods: We conducted a double-blind, placebo-controlled trial among patients with type 2 diabetes and microalbuminuria. Patients with type 2 diabetes received either 200 mg MOFs or placebo daily on top of their habitual diet and medication. The primary endpoint was the between-group difference of the change in 24-h Albumin Excretion Rate (AER) over three months. Secondary endpoints were the between-group differences of the change in plasma levels of different markers of endothelial dysfunction. Mixed-modelling was applied for the longitudinal analyses. Results: Participants (n = 97) were 63.0 ± 9.5 years old; diabetes-duration was 15.7 ± 8.5 years. Median baseline AER was 60 (IQR 20–120) mg/24 h. There was no within-group difference in median change of AER from baseline to 3 months in the intervention (0 (-35-21) mg/24 h, p = 0.41) or the control group (0 (-20-10) mg/24 h, p = 0.91). There was no between-group difference in the course of AER over three months (log-transformed data: β = −0.02 (95%CI -0.23-0.20), p = 0.88), nor in the plasma levels of the endothelial dysfunction markers. Conclusion: Daily 200 mg MOFs for three months on top of habitual diet and usual care did not reduce AER and plasma markers of endothelial dysfunction compared to placebo, in patients with long-term type 2 diabetes and microalbuminuria. Clinical trials registration: NTR4669, www.trialregister.nl.

Original languageEnglish
Pages (from-to)5587-5594
Number of pages8
JournalClinical Nutrition
Volume40
Issue number11
DOIs
Publication statusPublished - 1 Nov 2021

Bibliographical note

Funding Information:
This trial was partly funded by I.N.C. Agency B.V., Loosdrecht, the Netherlands . The funder had an advisory role in the study design and had no role in the collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication.

Publisher Copyright:
© 2021 The Author(s)

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