Polycystic Ovary SyndromeNCT05348967
Combination of D-chiro-inositol With Ketogenic Diet
A study testing TECADRIOL in people with Polycystic Ovary Syndrome, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- TECADRIOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with age between 25 and 40 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS)
- Diagnosis of insulin-resistance (HOMA ≥2.5)
- 26 ≤ BMI ≤32
Who cannot join
- Subjects with no indication for treatment
- Pregnancy, breastfeeding
- Treatment with drugs or supplements that interfere with the mechanism of action of insulin
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- TECADRIOL
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECADRIOLDietary supplement
Food supplement with D-chiro-inositol and alpha-lactalbumin
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Ketogenic diet |
| TECADRIOL | Experimental | Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin Receives: Dietary Supplement: TECADRIOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA index
Reduction of HOMA index
Measured: Three time points: change in HOMA index from the baseline to 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start14 Oct 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: No partecipants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348967
- Sponsor's protocol ID
- DCI_KETO22
- Status last verified
- May 2025
- First submitted
- 22 Apr 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05348967
- Acronym / sponsor ID
- DCI_KETO22
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No partecipants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Ketogenic diet |
| TECADRIOL | Experimental | Dietary Supplement: TECADRIOLKetogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with age between 25 and 40 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS)
- Diagnosis of insulin-resistance (HOMA ≥2.5)
- 26 ≤ BMI ≤32
Key exclusion criteria (3 listed)
- Subjects with no indication for treatment
- Pregnancy, breastfeeding
- Treatment with drugs or supplements that interfere with the mechanism of action of insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECADRIOLFood supplement with D-chiro-inositol and alpha-lactalbumin | Dietary supplement | TECADRIOL |
Primary outcome
HOMA index
Time frame: Three time points: change in HOMA index from the baseline to 2 and 4 months
Reduction of HOMA index
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECADRIOL in people with Polycystic Ovary Syndrome, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA index (time frame: Three time points: change in HOMA index from the baseline to 2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.