Weight LossPhase 4POSONCT04375696
Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
A Phase 4 study testing Polyglucosamine L112 in people with Weight Loss, run by Certmedica International GmbH at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Polyglucosamine L112
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 24 Apr 2020to 20 Dec 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age between 18-65
- Both sexes - mandatory adequate contraceptive method for women in fertility age
- BMI between 25-32 kg/m2 and weigh in > 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year
- No 3 kg weight fluctuation in the last 3 months
- Beck Depression Inventory (BDI) score < 20
- Binge Eating Scale (BES) score < 27
Who cannot join
- Shellfish allergy or to any other ingredient in the product
- Previous diet-therapy attempts with at least a 5% weight loss in the last year
- 3 kg weight fluctuation in the last 3 months
- Presumed or confirmed pregnancy
- No contraceptive method for women in fertility age
- Cardiopathies, nephropathies, hepatopathies, bronchopneumopathies, hemopathies dermopathies clinically significant chronic degenerative CNS (Central Nervous System) diseases
Show all 15Show fewer
- Active peptic ulcer, ulcerative colitis, Crohn disease, celiac disease, inflammatory bowel disease
- Alcoholism
- Epilepsy
- Past or current malignancies
- Intellectual disability
- Significant motor disability
- Drug abuse
- Autoimmune diseases
- Symptomatic cholelithiasis
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
Pavia, Lombardy, 27100
About this study
Official title: Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)
The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
Read the detailed description
The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The secondary objectives of the study are:
- to evaluate the effect of supplementation on blood triglyceride levels
- to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT), LDL, and HDL
- to evaluate the effect of supplementation on glucose, insulin, insulin resistance assessed by calculating the Homeostatic metabolic assessment (HOMA)
- to evaluate the effect of supplementation on liver enzymes (transaminases) and renal function (creatinine)
- to evaluate the effect of supplementation on BMI (Body Mass Index)
- to evaluate the effect of supplementation on the abdominal circumference
- to evaluate the effect of supplementation on body composition evaluated by dual X-ray densitometer (DXA)
- to evaluate the effect of supplementation on the serum levels of reactive oxygen species
- to evaluate the effect of supplementation on serum antioxidant capacity
- Conditions
- Weight Loss
- Being tested
- Polyglucosamine L112, Placebo
- Keywords
- Polyglucosamine, Formoline L112, Medical Device
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglucosamine L112Drug
Also called Formoline L112
Polyglucosamine; Ascorbic Acid; Tartaric Acid
PlaceboOther
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
| Study group | Role | What they receive |
|---|---|---|
| Product | Experimental | 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg Receives: Drug: Polyglucosamine L112 |
| Placebo | Placebo comparator | 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Measured: 3-month treatment
Secondary outcomes (9)
Triglycerides
To evaluate the effect of PG administration on triglycerides plasma levels
Measured: 3-month treatment
Cholesterol
To evaluate the effect of PG administration on total cholesterol plasma levels
Measured: 3-month treatment
HOMA
To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA
Measured: 3-month treatment
Hepatic Enzymes - Renal Functionality
To evaluate the effect of PG administration on transaminases and creatinine
Measured: 3-month treatment
BMI
To evaluate the effect of PG administration on BMI
Measured: 3-month treatment
Abdominal Circumference
To evaluate the effect of PG administration on the abdominal circumference
Measured: 3-month treatment
DXA
To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)
Measured: 3-month treatment
ROS
To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels
Measured: 3-month treatment
Antioxidant Serum Capacity
To evaluate the effect of PG administration on serum antioxidant capacity
Measured: 3-month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start24 Apr 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariangela Rondanelli, Prof., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375696
- Sponsor's protocol ID
- IT-1501202
- Acronym
- POSO
- Status last verified
- Nov 2022
- First submitted
- 30 Apr 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rondanelli M, Perna S, Porta MD, Lombardoni F, Patelli Z, Nichetti M, Gasparri C, Pistolesi E, Cestaro B, Cazzola R. Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation. BMC Nutr. 2025 Sep 2;11(1):170. doi: 10.1186/s40795-025-01153-8.
PubMed 40898346
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)
- ClinicalTrials.gov ID
- NCT04375696
- Acronym / sponsor ID
- POSO / IT-1501202
- Conditions
- Weight Loss
- Keywords
- Polyglucosamine, Formoline L112, Medical Device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 5 May 2020 (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 purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
Detailed description
The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The secondary objectives of the study are:
- to evaluate the effect of supplementation on blood triglyceride levels
- to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT), LDL, and HDL
- to evaluate the effect of supplementation on glucose, insulin, insulin resistance assessed by calculating the Homeostatic metabolic assessment (HOMA)
- to evaluate the effect of supplementation on liver enzymes (transaminases) and renal function (creatinine)
- to evaluate the effect of supplementation on BMI (Body Mass Index)
- to evaluate the effect of supplementation on the abdominal circumference
- to evaluate the effect of supplementation on body composition evaluated by dual X-ray densitometer (DXA)
- to evaluate the effect of supplementation on the serum levels of reactive oxygen species
- to evaluate the effect of supplementation on serum antioxidant capacity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product | Experimental | Drug: Polyglucosamine L11275 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg |
| Placebo | Placebo comparator | Other: Placebo75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent
- Age between 18-65
- Both sexes - mandatory adequate contraceptive method for women in fertility age
- BMI between 25-32 kg/m2 and weigh in > 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year
- No 3 kg weight fluctuation in the last 3 months
Key exclusion criteria (15 listed)
- Shellfish allergy or to any other ingredient in the product
- Previous diet-therapy attempts with at least a 5% weight loss in the last year
- 3 kg weight fluctuation in the last 3 months
- Presumed or confirmed pregnancy
- No contraceptive method for women in fertility age
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 |
|---|---|---|
| Polyglucosamine L112Also: Formoline L112Polyglucosamine; Ascorbic Acid; Tartaric Acid | Drug | Product |
| PlaceboDicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide | Other | Placebo |
Primary outcome
Weight Loss
Time frame: 3-month treatment
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
9 secondary outcomes
Triglycerides
Time frame: 3-month treatment
Cholesterol
Time frame: 3-month treatment
HOMA
Time frame: 3-month treatment
Hepatic Enzymes - Renal Functionality
Time frame: 3-month treatment
BMI
Time frame: 3-month treatment
Abdominal Circumference
Time frame: 3-month treatment
DXA
Time frame: 3-month treatment
ROS
Time frame: 3-month treatment
Antioxidant Serum Capacity
Time frame: 3-month treatment
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 22 Nov 2022.
- Derived from this study: PubMed 40898346Rondanelli M, Perna S, Porta MD, Lombardoni F, Patelli Z, Nichetti M, Gasparri C, Pistolesi E, Cestaro B, Cazzola R. Modification of metabolic syndrome parameters following the administration of polyglucosamine L112: results of a subgroup analysis of subjects enrolled in a double blind randomised placebo controlled clinical investigation. BMC Nutr. 2025 Sep 2;11(1):170. doi: 10.1186/s40795-025-01153-8.
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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.
Mariangela Rondanelli, Prof. principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyglucosamine L112 in people with Weight Loss, run by Certmedica International GmbH 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 7 inclusion and 15 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 22 Nov 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight Loss (time frame: 3-month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375696, which also lists 1 linked publication.
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 22 Nov 2022.