InositolNCT05448378
Evaluation of D-chiro-inositol Treatments
A study testing D-chiro-inositol in people with Inositol and Testosterone, run by Lo.Li.Pharma s.r.l at 2 sites in Italy.
Trial summary
Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inositol, Testosterone, Insulin
- What is being tested?
- D-chiro-inositol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Jun 2022to 16 Sep 2022
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good state of health;
- Regular menstrual cycle.
Who cannot join
- pregnancy;
- delivery in the previous 6 months;
- currently breastfeeding;
- menopause;
- alcohol or drug abuse;
- insulin resistance defined as HOMA-IR index greater than or equal to 2.5;
Show all 10Show fewer
- other medical morbidities, such as hypertension, PCOS, or diabetes;
- oligomenorrhea or amenorrhea;
- current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin);
- use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer
Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.
- Conditions
- Inositol, Testosterone, Insulin, Ovulation, Asprosin
- Being tested
- D-chiro-inositol
- Medical subject headings
- Insulin Resistance, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-chiro-inositolDietary supplement
D-chiro-inositol 600 mg twice per day on an empty stomach for one month
| Study group | Role | What they receive |
|---|---|---|
| D-chiro-inositol | Experimental | Patients will take D-chiro-inositol. We will make two blood sampling, at the baseline and after one-month treatment Receives: Dietary Supplement: D-chiro-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
Serum values of testosterone
Measured: 30 days
Secondary outcomes (9)
BMI
body-mass index
Measured: 30 days
Glycemia
Serum values of glucose
Measured: 30 days
Insulinemia
Serum values of insulin
Measured: 30 days
HOMA-IR index
Model of assessment for insulin resistance
Measured: 30 days
FSH
Serum values of FSH
Measured: 30 days
LH
Serum values of LH
Measured: 30 days
Estradiol
Serum values of estradiol
Measured: 30 days
DHEAS
Serum values of DHEAS
Measured: 30 days
Asprosin
Serum values of asprosin
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start4 Jun 2022
- Primary completion30 Aug 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InositolStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Human healthy women
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05448378
- Sponsor's protocol ID
- DCI-Evaluation
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 19 Sep 2022
- 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 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer
- ClinicalTrials.gov ID
- NCT05448378
- Acronym / sponsor ID
- DCI-Evaluation
- Conditions
- Inositol, Testosterone, Insulin, Ovulation, Asprosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 7 Jul 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.
Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Human healthy women
| Arm | Type | Receives |
|---|---|---|
| D-chiro-inositol | Experimental | Dietary Supplement: D-chiro-inositolPatients will take D-chiro-inositol. We will make two blood sampling, at the baseline and after one-month treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good state of health;
- Regular menstrual cycle.
Key exclusion criteria (10 listed)
- pregnancy;
- delivery in the previous 6 months;
- currently breastfeeding;
- menopause;
- alcohol or drug abuse;
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 |
|---|---|---|
| D-chiro-inositolD-chiro-inositol 600 mg twice per day on an empty stomach for one month | Dietary supplement | D-chiro-inositol |
Primary outcome
Testosterone
Time frame: 30 days
Serum values of testosterone
9 secondary outcomes
BMI
Time frame: 30 days
Glycemia
Time frame: 30 days
Insulinemia
Time frame: 30 days
HOMA-IR index
Time frame: 30 days
FSH
Time frame: 30 days
LH
Time frame: 30 days
Estradiol
Time frame: 30 days
DHEAS
Time frame: 30 days
Asprosin
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Inositol
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
PCOS (Polycystic Ovary Syndrome), Insulin Resistance
Active, not recruiting
Myo-Inositol and Folic Acid for Improving Inflammation in Polycystic Ovary Syndrome
Inflammation Biomarkers, Poly Cystic Ovary Syndrome
Recruiting
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Thyroid Nodule
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-chiro-inositol in people with Inositol and Testosterone, run by Lo.Li.Pharma s.r.l at 2 sites 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Testosterone (time frame: 30 days). 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 19 Sep 2022.