Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02633150
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2015-12-09
Brief Title:
Assessing the Value of Red Grapes Polyphenol Supplementation on Metabolic Parameters in Obese Insulinoresistant Subjects
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Assessing the Value of Red Grapes Polyphenol Supplementation on Metabolic Parameters in Obese Insulinoresistant Subjects Study Randomized Versus Placebo
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
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:
POLYGIR
Brief Summary:
Obesity chronic disease is a real public health problem because of its high prevalence but also because of the high risk of complications including insulin resistance IR and type 2 diabetes T2D The mechanisms involved in the development of IR are not well known Oxidative stress and inflammation induced by food overload could be the initiators IR mechanisms in skeletal muscle responsible for the use of nearly 80 glucose in response to insulin and therefore plays a major role in the regulation of glucose metabolism Thus an increase in ROS Reactive Oxygen Species markers of oxidative stress and chronic low-grade inflammation have been demonstrated in subjects with obesity the latter decreasing in weight loss Therapeutically loosing weight is still very difficult these days because of the complexity of this chronic disease Thus it is well established that restrictive diets to expose weight rebound dramatic medically as in human terms for these patients Support for physical activity is also difficult because of reduced mobility in patients refer to the lack of motivation among some Finally investigators have no treatment against-obesity who have demonstrated a benefit risk enough to be used routinely It is therefore essential to seek other means of struggle against the IR see help in weight loss
In parallel it is well established that the consumption of certain antioxidants including polyphenols PP grape as extracts and whole foods modulates favorably several pathways responsible for the development of IR in cell models animals The results of antioxidants supplementation in humans are few and controversial However most supplementation studies in human used a PP Resveratrol at supra nutritional doses ie not compatible with a balanced diet of fruits and vegetables In a previous study investigators tested the interest of a supplementation with red grape PP nutritional doses in healthy subjects with metabolic risk overweight subjects and related to the first degree of T2DM patients on IR hyperinsulinemic euglycemic clamp measured During this study the PP have prevented the central mechanisms of muscle IR that are oxidative stress and mitochondrial dysfunction induced by a load fructose
For this project investigators propose to test the effect of a red grape PP supplementation at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant This is a double-blind randomized placebo-controlled This supplementation will be associated with a standard support for their obesity performed routinely in the Nutrition and Diabetes unit
Specific inclusion criteria Female or male nondiabetic 50-65 years BMI 30 kg m2 and with a HOMA 3
The main objective is to test whether supplementation PP improves systemic insulin sensitivity GIR rate glucose infusion measured by hyperinsulinemic-euglycemic clamp gold standard for measuring insulin sensitivity in insulin-resistant obese subjects
Secondary objectives are to
Test whether supplementation PP improves insulin sensitivity to tissue fat and muscle and compare the response to supplementation in these two tissues
Determining the cellular and molecular mechanisms involved in improving IR regulation of inflammation oxidative stress
Determine whether supplementation PP optimizes weight reduction compared to a standard single support
NSN The number of subjects required was evaluated from our previous work 2013 Hokayem et al Whose main objective was to assess the impact of PD versus placebo in first degree relatives of patients with diabetes type 2 Under a bilateral alternative hypothesis of a nonparametric test Mann-Whitney 1 1 ratio a power of 80 and an alpha risk of 005 the number of subjects was estimated at 15 per group
Methodology Anthropometric measurements assessment of body composition DEXA system application characterization metabolism inflammation oxidative stress adipokines and insulin sensitivity clamp hyperinsulinemic-euglycemic lipopolysaccharides LPS tissue characterization biopsies of skeletal muscle and tissue adipose insulin sensitivity inflammation oxidative stress gene regulation sirt1 mitochondrial activity cell characterization adipocyte precursor and muscle insulin sensitivity inflammation oxidative stress sirt1
Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese patients refer to optimize weight loss compared to a standardized management of obesity and determine the mechanisms involved
In parallel it is well established that the consumption of certain antioxidants including polyphenols PP grape as extracts and whole foods modulates favorably several pathways responsible for the development of IR in cell models animals The results of antioxidants supplementation in humans are few and controversial However most supplementation studies in human used a PP Resveratrol at supra nutritional doses ie not compatible with a balanced diet of fruits and vegetables In a previous study investigators tested the interest of a supplementation with red grape PP nutritional doses in healthy subjects with metabolic risk overweight subjects and related to the first degree of T2DM patients on IR hyperinsulinemic euglycemic clamp measured During this study the PP have prevented the central mechanisms of muscle IR that are oxidative stress and mitochondrial dysfunction induced by a load fructose
For this project investigators propose to test the effect of a red grape PP supplementation at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant This is a double-blind randomized placebo-controlled This supplementation will be associated with a standard support for their obesity performed routinely in the Nutrition and Diabetes unit
Specific inclusion criteria Female or male nondiabetic 50-65 years BMI 30 kg m2 and with a HOMA 3
The main objective is to test whether supplementation PP improves systemic insulin sensitivity GIR rate glucose infusion measured by hyperinsulinemic-euglycemic clamp gold standard for measuring insulin sensitivity in insulin-resistant obese subjects
Secondary objectives are to
Test whether supplementation PP improves insulin sensitivity to tissue fat and muscle and compare the response to supplementation in these two tissues
Determining the cellular and molecular mechanisms involved in improving IR regulation of inflammation oxidative stress
Determine whether supplementation PP optimizes weight reduction compared to a standard single support
NSN The number of subjects required was evaluated from our previous work 2013 Hokayem et al Whose main objective was to assess the impact of PD versus placebo in first degree relatives of patients with diabetes type 2 Under a bilateral alternative hypothesis of a nonparametric test Mann-Whitney 1 1 ratio a power of 80 and an alpha risk of 005 the number of subjects was estimated at 15 per group
Methodology Anthropometric measurements assessment of body composition DEXA system application characterization metabolism inflammation oxidative stress adipokines and insulin sensitivity clamp hyperinsulinemic-euglycemic lipopolysaccharides LPS tissue characterization biopsies of skeletal muscle and tissue adipose insulin sensitivity inflammation oxidative stress gene regulation sirt1 mitochondrial activity cell characterization adipocyte precursor and muscle insulin sensitivity inflammation oxidative stress sirt1
Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese patients refer to optimize weight loss compared to a standardized management of obesity and determine the mechanisms involved
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-A01627-40 | REGISTRY | ID RCB | None |