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Efficacy of Polyglucosamine Long Term Treatment

NCT02682277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-07-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

polygucosamine

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

OTHER

placebo

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

Sponsors & Collaborators

  • Certmedica International GmbH

    lead INDUSTRY

Principal Investigators

  • Gianni Belcaro · Irwine Labs University of Chieti

  • Umberto Cornelli, MD · Loyola University School of Medicine-Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682277 on ClinicalTrials.gov