Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05348967
Status:
UNKNOWN
Last Update Posted:
2022-12-27
First Post:
2022-04-22
Brief Title:
Combination of D-chiro-inositol With Ketogenic Diet
Sponsor:
LoLiPharma srl
Organization:
LoLiPharma srl
Study Overview
Official Title:
Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of OverweightObese Patients With Insulin Resistance and Polycystic Ovary Syndrome
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
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 study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolicendocrine picture of overweightobese women with PCOS with insulin resistance in a shorter time than the ketogenic diet alone
Detailed Description:
Weight loss is the main approach to counteract PCOS phenotype improving ovulatory function and reducing insulin and systemic levels of free testosterone
It is not yet ascertained whether the composition of the diet can have a positive effect on the metabolic pattern however it should be considered that blood glucose levels are influenced by the intake of carbohydrates that regulate insulin secretion
Therefore low-carbohydrate diets should be preferred over standard low-calorie diets in terms of improvement in metabolicendocrine parameters which accompanies weight loss in women with PCOS
The ketogenic diet KD a very low-carbohydrate diet capable of developing physiological ketosis has proven very effective aganist various pathological conditions including obesity and type 2 diabetes
In particular in the context of KD there is an ever increasing interest in VLCKD Very Low Calorie Ketogenic Diet diets with very low calorie content as well as carbohydrates which have been shown to be effective and safe in the management of metabolic diseases
Evidence on the efficacy of this diet in PCOS women is still rather scarce An uncontrolled pilot study in which VLCKD was followed by 11 overweightobese women with PCOS for a period of 24 weeks demonstrated a significant reduction in body weight free testosterone LH to FSH ratio and especially fasting insulin suggesting favorable effects in PCOS patients
It has been widely demonstrated that the supplementation of inositols polyols with insulin-sensitizing action can normalize the metabolicendocrine picture of PCOS patients who are overweightobese and insulin resistant avoiding the typical gastrointestinal side effects of classic insulin sensitizers
A recent study on overweightobese women with PCOS has shown that the association of low-calorie diet with inositol supplementation accelerates weight loss contributing to the restoration of the menstrual cycle
Therefore considering the results of this study and bearing in mind the literature that reports that D-chiro-inositol improves glucose tolerance and increases insulin sensitivity in hyperinsulinemic women with polycystic ovary syndrome we want to investigate whether supplementation with D-chiro-inositol in association with VLCKD can improve the metabolicendocrine profile of overweightobese insulin resistant PCOS women in a shorter time than with VLCKD alone
This would reduce the period in which patients undergo the VLCKD diet allowing them to follow a less restrictive and subsequently maintenance diet in the shortest possible time
It is not yet ascertained whether the composition of the diet can have a positive effect on the metabolic pattern however it should be considered that blood glucose levels are influenced by the intake of carbohydrates that regulate insulin secretion
Therefore low-carbohydrate diets should be preferred over standard low-calorie diets in terms of improvement in metabolicendocrine parameters which accompanies weight loss in women with PCOS
The ketogenic diet KD a very low-carbohydrate diet capable of developing physiological ketosis has proven very effective aganist various pathological conditions including obesity and type 2 diabetes
In particular in the context of KD there is an ever increasing interest in VLCKD Very Low Calorie Ketogenic Diet diets with very low calorie content as well as carbohydrates which have been shown to be effective and safe in the management of metabolic diseases
Evidence on the efficacy of this diet in PCOS women is still rather scarce An uncontrolled pilot study in which VLCKD was followed by 11 overweightobese women with PCOS for a period of 24 weeks demonstrated a significant reduction in body weight free testosterone LH to FSH ratio and especially fasting insulin suggesting favorable effects in PCOS patients
It has been widely demonstrated that the supplementation of inositols polyols with insulin-sensitizing action can normalize the metabolicendocrine picture of PCOS patients who are overweightobese and insulin resistant avoiding the typical gastrointestinal side effects of classic insulin sensitizers
A recent study on overweightobese women with PCOS has shown that the association of low-calorie diet with inositol supplementation accelerates weight loss contributing to the restoration of the menstrual cycle
Therefore considering the results of this study and bearing in mind the literature that reports that D-chiro-inositol improves glucose tolerance and increases insulin sensitivity in hyperinsulinemic women with polycystic ovary syndrome we want to investigate whether supplementation with D-chiro-inositol in association with VLCKD can improve the metabolicendocrine profile of overweightobese insulin resistant PCOS women in a shorter time than with VLCKD alone
This would reduce the period in which patients undergo the VLCKD diet allowing them to follow a less restrictive and subsequently maintenance diet in the shortest possible time
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