Efficacy and Safety of Nutraceuticals in Patients With Diabetes Mellitus Type II and Dyslipidemia.

Summary

The presence of dyslipidemia, is a significant cardiovascular risk factor. This factor, however, determines the three-fold increase in cardiometabolic risk when an isolated or mixed dyslipidemia is associated with the presence of diabetes mellitus. Diabetes mellitus is a metabolic alteration resulting in a decrease in insulin secondary to reduced availability of this hormone or an impediment to its normal action or a combination of these factors. . Under normal conditions, the vascular endothelium responds to short-term increases in flow by releasing NO and other endothelium-dependent relaxing factors that dilate the artery. Flow-mediated dilation(FMD) is impaired in atherosclerotic coronary arteries. The supplementation with polyphenols of olive leaves, bergamot extract, gymnema sylvatic extract (gymnemic acid) and phaseolamin (bean protein) significantly improves the glico-lipid balance through an improvement in liver function, an inhibition to more levels of lipid metabolism .

Recently, it has been documented how the polyphenolic fraction extracted from bergamot (BPF) administered orally both in animal models with induced hyperlipidemia diet, and in patients with metabolic syndrome, produces a significant and substantial reduction of serum cholesterol, triglycerides and blood levels of glucose. This effect was accompanied by an important improvement in vascular reactivity in patients with hyperlipidemia and high blood sugar, suggesting the potential protective role of BPF in patients with metabolic syndrome and elevated cardiovascular risk.

Oleuropeina (Olea Europaea) is also characterized by a peculiar polyphenolic profile. Both fruits and leaves, thanks to their cardioprotective activity, are used as antihypertensive agents and in the treatment of vascular disorders. The gymnemic acid (glycosidic triterpene), extracted from the leaves of Gymnema Sylvestre, is the representative element of the plant. Thanks to its presence in the phytocomplex, it carries out a hypoglycaemic action through two main mechanisms: inhibition of intestinal sugar absorption and increased metabolic transformation of glucose at the cellular level.

To better define the interrelations of systemic CRFs, FMD, and effects of chronic nutraceutical supplements we performed clinical evaluations and ultrasound measurements of the flow and diameter responses to forearm cuff occlusion in a large, well characterized community-based cohort.

Conditions

• Diabetes Mellitus, Type 2
• Nutritional and Metabolic Diseases
• Vascular System Injury
• Therapy-Related Morphologic Change

Interventions

DRUG

Nutriceutical Oral Capsule,

nutraceutical 920 mg (Bergamot 450 mg, Gymnema (400 mg, Phaseolamine 30 mg, Olea Europaea 10 mg) twice day , 12 weeks

DRUG

Placebo Oral Tablet

placebo tablet twice a day twenty minutes before main meals, for 12 weeks,

Sponsors & Collaborators

• University Magna Graecia

  collaborator OTHER

• Villa dei Gerani

  lead OTHER

Principal Investigators

• Capomolla Antonio, MD · Villa dei Gerani

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2018-03-26

Completion

2018-03-26

Countries

• Italy

Study Locations