ObesityNCT05022732
Polyglucosamine L112 in Overweight and Obese Subjects
A study testing Polyglucosamine L112 in people with Obesity, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Polyglucosamine L112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2020to 19 Aug 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- weight > 75 Kg
- absence of previous diet therapy attempts
- no fluctuation of at least 3 kg in the previous 3 months
- Beck Depression Inventory score < 20 pt
- Binge Eating Scale score < 27 pt
Who cannot join
- allergy to shellfish
- pregnancy or breast feeding
- presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
- presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
- symptomatic cholelithiasis
- previous or current neoplasms
Show all 13Show fewer
- epilepsy
- obesity secondary to endocrinopathies or genetic syndromes
- significant motor disability or mental retardation
- major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia
- previous history or current diagnosis of drug abuse or alcoholism
- changing in smoking habits or quitting smoking in the last 6 months
- current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects
This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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
- Conditions
- Obesity
- Being tested
- Polyglucosamine L112, Placebo
- Keywords
- Obesity, Polyglucosamine, Body composition, Inflammation
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglucosamine L112Dietary supplement
750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients
PlaceboCombination product
excipients and gum arabic
| Study group | Role | What they receive |
|---|---|---|
| Control formula | Placebo comparator | Excipients and gum arabic in tablet Receives: Combination Product: Placebo |
| Experimental formula | Active comparator | Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients) Receives: Dietary Supplement: Polyglucosamine L112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on anthropometric measures
Body weight (Kg)
Measured: Changes from baseline anthropometric measures at 90 days
Secondary outcomes (12)
Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Measured: Changes from baseline lipid profile at 90 days
Changes on insulin resistance
Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4
Measured: Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile
Glycemia (mg/dl)
Measured: Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile
Insulin (mcU/ml)
Measured: Changes from baseline Carbohydrate profile at 90 days
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Measured: Changes from baseline safety at 90 days
Changes on safety
Gamma glutamyl transferase (U/I)
Measured: Changes from baseline safety at 90 days
Changes on safety
Creatinine (mg/dl)
Measured: Changes from baseline safety at 90 days
Changes on anthropometric measures
Waist circumference (cm)
Measured: Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures
Body Mass Index (Kg/m2)
Measured: Changes from baseline anthropometric measures at 90 days
Changes on body composition
Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Measured: Changes from baseline body composition at 90 days
Changes on oxidative stress
Reactive Oxygen Species (CARR U)
Measured: Changes from baseline oxidative stress at 90 days
Changes on oxidative stress
Total Antioxidant Capacity (ORAC U)
Measured: Changes from baseline oxidative stress at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start5 May 2020
- Primary completion5 Aug 2020
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariangela Rondanelli, Principal investigator, Fondazione Casemiro Mondino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022732
- Sponsor's protocol ID
- 20200037586
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT05022732
- Acronym / sponsor ID
- 20200037586
- Conditions
- Obesity
- Keywords
- Obesity, Polyglucosamine, Body composition, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 26 Aug 2021 (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.
This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control formula | Placebo comparator | Combination Product: PlaceboExcipients and gum arabic in tablet |
| Experimental formula | Active comparator | Dietary Supplement: Polyglucosamine L112Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- weight > 75 Kg
- absence of previous diet therapy attempts
- no fluctuation of at least 3 kg in the previous 3 months
- Beck Depression Inventory score < 20 pt
- Binge Eating Scale score < 27 pt
Key exclusion criteria (13 listed)
- allergy to shellfish
- pregnancy or breast feeding
- presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
- presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
- symptomatic cholelithiasis
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 L112750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients | Dietary supplement | Experimental formula |
| Placeboexcipients and gum arabic | Combination product | Control formula |
Primary outcome
Changes on anthropometric measures
Time frame: Changes from baseline anthropometric measures at 90 days
Body weight (Kg)
12 secondary outcomes
Changes on lipid profile
Time frame: Changes from baseline lipid profile at 90 days
Changes on insulin resistance
Time frame: Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on safety
Time frame: Changes from baseline safety at 90 days
Changes on safety
Time frame: Changes from baseline safety at 90 days
Changes on safety
Time frame: Changes from baseline safety at 90 days
Changes on anthropometric measures
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on body composition
Time frame: Changes from baseline body composition at 90 days
Changes on oxidative stress
Time frame: Changes from baseline oxidative stress at 90 days
Changes on oxidative stress
Time frame: Changes from baseline oxidative stress at 90 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 26 Aug 2021.
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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 principal investigator
Fondazione Casemiro Mondino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglucosamine L112 in people with Obesity, run by Azienda di Servizi alla Persona di Pavia 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 5 inclusion and 13 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 26 Aug 2021. 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.
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?
Changes on anthropometric measures (time frame: Changes from baseline anthropometric measures at 90 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 26 Aug 2021.