Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes and microalbuminuria

It is well known that chronic complications of type 2 diabetes mellitus (T2D),
such as nephropathy, reduce the quality of life of patients substantially, are
a heavy burden to the health care system, and increase diabetic mortality.
Micro albuminuria is a good proxy of endothelial function in T2D patients and
it is strongly associated with cardiovascular outcome and renal health. It is
routinely measured in T2D patients to evaluate renal status.A recent
publication of the ADVANCE trial showed that the moderate consumption of
alcohol, particularly wine, reduced cardiovascular events, microvascular
complications and all-cause mortality in patients with T2D. Over the past
decades, researchers have wondered which compounds in wine could be responsible
for the lower risk of cardiovascular disease. Monomeric and oligomeric
flavanols (MOF) in the proanthocyanidin subclass have been suggested as a
candidate to explain the cardioprotective effects of red wine. Previous studies
have indeed shown an improvement in vascular function in patients with T2D
using MOF (see page 10/11 of study protocol). If we can show that the use of
MOF in the dietary treatment of patients with T2D has a positive physiological
effect on the renal-endothelial health of patients with T2D , we will have
another dietary treatment option to improve renal health in this patient group.

The objective of this study is to determine whether monomeric and oligomeric
flavanols have a beneficial effect on renal-endothelial function in the dietary
management of T2D, as reflected by improvement of AER and renal-endothelial
biomarkers

this study is a dubbel blinded, randomised, placebo controlled trial.

During 3 months, participants will take a placebo or a Food for Special Medical
Purposes (FSMP) containing 200 mg of monomeric and oligomeric flavanols daily.

The burden of this study for the participants consists of the intake of the MOF
FSMP/placebo for 3 months, visiting the outpatient diabetes clinic 4 times (30
min/visit), filling in 3 questionnaires 3 times (30 min/3 questionnaires),
collecting blood samples 2 times and collecting 24h urine at home 3 times.
The intake of the MOF FSMP is generally well-tolerated and not associated with
any serious negative effects. The risk is therefor considered to be minimal,
as described in the research protocol (page 33). The risk associated with the
urine collection and intra-venous punctures is also considered low.