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Combination of D-chiro-inositol With Ketogenic Diet

Primary Purpose

Polycystic Ovary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TECADRIOL
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Sapienza University of RomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

TECADRIOL

Arm Description

Ketogenic diet

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

Outcomes

Primary Outcome Measures

HOMA index
Reduction of HOMA index

Secondary Outcome Measures

Full Information

First Posted
April 22, 2022
Last Updated
December 22, 2022
Sponsor
Lo.Li.Pharma s.r.l
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1. Study Identification

Unique Protocol Identification Number
NCT05348967
Brief Title
Combination of D-chiro-inositol With Ketogenic Diet
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Ketogenic diet
Arm Title
TECADRIOL
Arm Type
Experimental
Arm Description
Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
Intervention Type
Dietary Supplement
Intervention Name(s)
TECADRIOL
Intervention Description
Food supplement with D-chiro-inositol and alpha-lactalbumin
Primary Outcome Measure Information:
Title
HOMA index
Description
Reduction of HOMA index
Time Frame
Three time points: change in HOMA index from the baseline to 2 and 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Basciani, Dr
Phone
+393392378124
Email
sabrinabasciani@yahoo.it
Facility Information:
Facility Name
Sapienza University of Rome
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Basciani, Dr
Phone
+393392378124
Email
sabrinabasciani@yahoo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Combination of D-chiro-inositol With Ketogenic Diet

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