NCT02682277

Brief Summary

The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
Last Updated

July 25, 2017

Status Verified

February 1, 2017

Enrollment Period

2.4 years

First QC Date

February 10, 2016

Last Update Submit

July 21, 2017

Conditions

Obesity

Keywords

obesitybody weightoverweightweight losspolyglucosamineL112caloric restrictionphysical activity

Outcome Measures

Primary Outcomes (1)

  • Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.

    12 months

Secondary Outcomes (3)

  • Change of body weight in kg

    12 months

  • Change of BMI

    12 monts

  • Reduction of waist circumference

    12 months

Study Arms (2)

Medical device polyglucosamine

ACTIVE COMPARATOR

2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity

Device: polygucosamine

Placebo

PLACEBO COMPARATOR

2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity

Other: placebo

Interventions

polygucosamineDEVICE

2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Also known as: ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine
Medical device polyglucosamine
placeboOTHER

2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30 and \< 35
  • waist circumference of more than 88 cm for women and greater than 102 for men

You may not qualify if:

  • pregnancy or breast-feeding
  • alcohol abuse
  • drug abuse or drug addiction
  • inability to fulfill the criteria of the trial protocol
  • cancer diseases
  • malignant tumors
  • pre-existence of chronic intestinal disease
  • known hypersensitivity reactions to crustaceans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAP Center

Rende, Cosenza, 87036, Italy

Location

MeSH Terms

Conditions

ObesityBody WeightOverweightWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Gianni Belcaro

    Irwine Labs University of Chieti

    PRINCIPAL INVESTIGATOR

  • Umberto Cornelli, MD

    Loyola University School of Medicine-Chicago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 31, 2016

Last Updated

July 25, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)