Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial

Abstract

BackgroundPatients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications. Monomeric and oligomeric flavanols (MOF) isolated from grape seeds (Vitis vinifera) have been linked to improved endothelial function and vascular health. The aim of this study is to determine the effect of a daily supplementation of 200 mg MOF on renal endothelial function of patients with T2D and microalbuminuria.Methods/designFor this double-blind, placebo-controlled, randomized, multicenter trial 96 individuals (ages 40–85 years) with T2D and microalbuminuria will be recruited. Participants will be randomly assigned to the intervention group, receiving 200 mg of MOF daily for 3 months, or to the control group, receiving a placebo. The primary endpoint is the evolution over time in albumin excretion rate (AER) until 3 months of intervention as compared with placebo. Secondary endpoints are the evolution over time in established plasma markers of renal endothelial function—asymmetric dimethylarginine (ADMA), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intercellular cell adhesion molecule-1 (sICAM-1), interleukin-6 (IL-6), and von Willebrand Factor (vWF)—until 3 months of intervention as compared with placebo. Mixed modeling will be applied for the statistical analysis of the data.DiscussionWe hypothesize that T2D patients with microalbuminuria have a medically determined requirement for MOF and that fulfilling this requirement will result in a decrease in AER and related endothelial biomarkers. If confirmed, this may lead to new insights in the dietary management of patients with T2D.Trial registrationNederlands Trial Register, NTR4669, registered on 7 July 2014.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2762-9) contains supplementary material, which is available to authorized users.

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

“…The FLAVA-trial was a double-blind, randomized controlled trial. The protocol of this trial has been published previously [28]. Adult patients with T2D and microalbuminuria were recruited between December 2014 and April 2019 from the outpatient diabetes clinics of four health care centers in Rotterdam, the Netherlands.…”

Health Effects of Grape Seed and Skin Extracts and Their Influence on Biochemical Markers

“…An interesting study carried out by Professor Rashid’s team of researchers [ 25 ] showed that monomeric and oligomeric flavanols isolated from grape seeds were able to improve the condition of patients with microalbuminuria and had a positive effect on renal endothelial function in patients with diabetes mellitus.…”