Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04488653
Status:
UNKNOWN
Last Update Posted:
2021-08-26
First Post:
2020-07-23
Brief Title:
A Study to Determine the Safety and Efficacy of Oligopin on Metabolic Risk Factors in Subjects With Metabolic Syndrome
Sponsor:
Les Derives Resiniques et Terpeniques
Organization:
Les Derives Resiniques et Terpeniques
Study Overview
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:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 191 of the Canadian population 342 of the US population and 243 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 48-7 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 individuals 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
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 48-7 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 individuals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None