A Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine the Safety and Efficacy of Oligopin® on Metabolic Risk Factors in Subjects With Metabolic Syndrome

Status Active, not recruiting

Clinical Trial Summary

The safety and efficacy of Oligopin® will be compared against a placebo to evaluate the effect on metabolic risk factors in subjects with metabolic syndrome. During the 84-day study period it is hypothesized that HDL cholesterol will increase and systolic blood pressure will decrease therefore lowering CVD risk factors after supplementation with Oligopin®. Additionally, it is hypothesized that Oligopin® supplementation will reduce fasting glucose levels.

Clinical Trial Description

Metabolic syndrome (MetS) is a combination of risk factors for chronic conditions such as cardiovascular disease (CVD) and type 2 diabetes (T2D). These risk factors include obesity (particularly abdominal obesity), high blood pressure, elevated triglycerides, low high-density lipoprotein (HDL) cholesterol, and elevated fasting blood glucose. MetS reflects overnutrition and sedentary lifestyles as the prevalence of MetS increases concomitantly with these lifestyle choices. Most recent estimates suggest that approximately 19.1% of the Canadian population, 34.2% of the US population, and 24.3% of the European population have MetS. Significantly, the prevalence of MetS in adults aged 18-39 has increased dramatically over the last 2 decades.

MetS commonly precedes the development of CVD and is associated with a 2-fold increase in the risk of CVD mortality. MetS also increases the risk of developing T2D and is suggested to be extremely prevalent (90-95%) in Caucasian individuals diagnosed with T2D. Indeed, the presence of even one MetS risk factor early in life increases the chances of developing a chronic disease later in life. Currently, MetS risk factors are estimated to be present in 4.8-7% of individuals from 18 to 30 years of age. Therefore, preventing the development of or treating these risk factors earlier in life could reduce the development of chronic disease.

The pathogenic mechanisms of MetS remain to be fully elucidated, however insulin resistance (IR) appears to play a pivotal role in the initiation and progression of the syndrome. Abdominal obesity is a well-known contributor to IR. Abdominal fat accumulation increases the supply of free fatty acids (FFAs) to the liver and indirectly results in an increase in plasma low-density lipoprotein (LDL) cholesterol and a decrease in HDL cholesterol. IR also elevates fasting blood glucose levels due to the suppression of hepatic glycogen synthesis and impairs postprandial glucose control by reducing insulin stimulated glucose uptake by peripheral tissues.

There is a need for natural interventions that aid in the prevention and treatment of MetS risk factors as the prevalence of overnutrition and sedentary lifestyles continues to increase. This study will assess the ability of Oligopin® to improve abdominal obesity, fasting blood glucose, postprandial glucose and insulin response, and HDL-cholesterol levels as these outcomes reliably predict an individual's MetS risk. Oligopin® is a French Maritime Pine Bark Extract (FMPBE) obtained from the pine tree Pinus pinaster. It is rich in low molecular weight oligomeric procyanidins (OPC) with 20% of OPCs in the form of dimers as compared to the most studied FMPBE Pycogenol®, which contains only 5% of OPCs as dimers.

Recently, Oligopin® supplementation was shown to reduce CVD risk factors. In a randomized, double-blind, placebo-controlled clinical trial, Oligopin® consumption increased HDL cholesterol levels and reduced systolic blood pressure and oxidized LDL (oxLDL) levels in stage 1 hypertensive individuals. This is significant as low HDL was reported to be the most prevalent risk factor for the development of MetS in young adults. FMPBE supplementation has also been shown to reduce fasting glucose levels in individuals with T2D. Interestingly, FMPBE is a potent inhibitor of α-glucosidase, which catalyses the breakdown of oligosaccharides in the small intestine to permit glucose resorption. Therefore, it is possible that Oligopin® may reduce fasting glucose levels and control postprandial hyperglycemia. This randomized, double-blind, placebo-controlled study will determine the efficacy of Oligopin® to improve markers of metabolic risk in subjects with MetS. ;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

• NCT number: NCT04488653
• Study type: Interventional
• Source: Les Derives Resiniques et Terpeniques
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2020
• Completion date: January 10, 2022