Combination of D-chiro-inositol With Ketogenic Diet

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05348967

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: TECADRIOL	N/A

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 metabolic/endocrine 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 overweight/obese 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 metabolic/endocrine picture of PCOS patients, who are overweight/obese and insulin resistant, avoiding the typical gastrointestinal side effects of classic insulin sensitizers.

A recent study on overweight/obese 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 metabolic/endocrine profile of overweight/obese 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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of Overweight/Obese Patients With Insulin Resistance and Polycystic Ovary Syndrome

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Ketogenic diet
Experimental: TECADRIOL Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin	Dietary Supplement: TECADRIOL Food supplement with D-chiro-inositol and alpha-lactalbumin

Arm

Intervention/Treatment

No Intervention: Control

Ketogenic diet

Experimental: TECADRIOL

Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Dietary Supplement: TECADRIOL

Food supplement with D-chiro-inositol and alpha-lactalbumin

Outcome Measures

Primary Outcome Measures

HOMA index [Three time points: change in HOMA index from the baseline to 2 and 4 months]
Reduction of HOMA index

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with age between 25 and 40 years
Diagnosis of Polycystic Ovary Syndrome (PCOS)
Diagnosis of insulin-resistance (HOMA ≥2.5)
26 ≤ BMI ≤32

Exclusion Criteria:

Subjects with no indication for treatment
Pregnancy, breastfeeding
Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lo.Li.Pharma s.r.l

ClinicalTrials.gov Identifier:

NCT05348967

Other Study ID Numbers:

DCI_KETO22

First Posted:

Apr 27, 2022

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of Apr 27, 2022