Effect of Lycopene and Isoflavones on Glucose Metabolism
Status:
Withdrawn
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Type 2 diabetes mellitus (DM2) is a growing social health problem world-wide, in particular
with respect to its contribution to cardiovascular disease. The progressive increase in
prevalence of DM2 has reached epidemic proportion and is a major cause of morbidity and
mortality in all populations around the world. Conventional stepwise treatment of DM2
generally focuses on controlling blood glucose concentration. However, the risk for
side-effects associated with the use of pharmacological intervention often delays initiation
of therapy, with the potential implication on worsening morbidity and mortality from
complications. On the other hand, non-pharmacological intervention in the form of dietary
restrictions, exercise and weight loss, is safe but often difficult to accomplish. The
availability of nutrients that affect glucose and lipid metabolism would provide an important
practical tool to establish early intervention in newly diagnosed DM2 and perhaps even in
patients who are only "at risk" for DM2. The investigators have recently obtained preliminary
data on beneficial effects of combined supplementation of lycopene and isoflavones on glucose
metabolism of normoglycemic volunteers with insulin resistance. This clinical trial will
explore the role of isoflavones and lycopene dietary supplementation in the improvement of
glucose metabolism of patients at increased risk or with established but mild DM2. The
overall hypothesis is that supplementation of laflavon, provided as a new formulation that
increases bioavailability of the individual components (Laflavon CamMedica contains 7 mg of
Lycopene and 50 mg of Soy Isoflavones), determines improvement in glucose tolerance and
insulin resistance of patients with the metabolic syndrome and also reduces HbA1c in patients
with mild DM2.