Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-24

Study Completion Date

2021-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Polyglucosamine L112 in Overweight and Obese Subjects

NCT05022732

Obesity

COMPLETED NA

Efficacy of Polyglucosamine for Weight Loss

NCT02410785

Overweight and Obesity

COMPLETED NA

A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity

NCT06717425

Obesity

ACTIVE_NOT_RECRUITING PHASE2

RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

NCT02529631

Overweight Obesity

COMPLETED NA

A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

NCT04707313

Obesity

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Product

75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg

Group Type EXPERIMENTAL

Polyglucosamine L112

Intervention Type DRUG

Polyglucosamine; Ascorbic Acid; Tartaric Acid

Placebo

75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polyglucosamine L112

Polyglucosamine; Ascorbic Acid; Tartaric Acid

Intervention Type DRUG

Placebo

Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Formoline L112

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes