Metabolic SyndromeNCT05689710
The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
A study testing Inositol and alpha-lactalbumin in people with Metabolic Syndrome and Cardiac Fibrosis, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metabolic Syndrome, Cardiac Fibrosis
- What is being tested?
- Inositol and alpha-lactalbumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2022to Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
At least 3 of the following inclusion criteria:
- triglycerides levels ≥ 150 mg/dL
- HDL ≤ 40 mg/dL
- Fasting glycemia > 100 mg/dL <126 mg/dl
- Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg
- Hip circumference > 102 cm in men or 88 cm in women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis
- Conditions
- Metabolic Syndrome, Cardiac Fibrosis
- Being tested
- Inositol and alpha-lactalbumin
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inositol and alpha-lactalbuminDietary supplement
The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Experimental | Experimental | Dietary Supplement with inositols and alpha-lactalbumin Receives: Dietary Supplement: Inositol and alpha-lactalbumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days
Secondary outcomes (2)
Tryglicerides
Plasmatic levels of tryglicerides
Measured: Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Hypertension
sphygmomanometer
Measured: Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Dec 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Difficulties in enrollment and patient compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davide Grassi, MD, Principal investigator, UOC Medicina Interna e Nefrologia P.O. AQClaudio Ferri, MD, Principal investigator, UOC Medicina Interna e Nefrologia P.O. AQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689710
- Sponsor's protocol ID
- CARDIO_INO22
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2022
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
- ClinicalTrials.gov ID
- NCT05689710
- Acronym / sponsor ID
- CARDIO_INO22
- Conditions
- Metabolic Syndrome, Cardiac Fibrosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulties in enrollment and patient compliance
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Jan 2023 (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 the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Experimental | Experimental | Dietary Supplement: Inositol and alpha-lactalbuminDietary Supplement with inositols and alpha-lactalbumin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Inositol and alpha-lactalbuminThe administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days) | Dietary supplement | Experimental |
Primary outcome
Body weight
Time frame: Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days
2 secondary outcomes
Tryglicerides
Time frame: Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Hypertension
Time frame: Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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.
Davide Grassi, MD principal investigator
UOC Medicina Interna e Nefrologia P.O. AQ
Claudio Ferri, MD principal investigator
UOC Medicina Interna e Nefrologia P.O. AQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inositol and alpha-lactalbumin in people with Metabolic Syndrome and Cardiac Fibrosis, 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.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Dec 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?
Results are not available in the source record.
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?
Body weight (time frame: Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 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 30 Dec 2025.