NCT02410785

Brief Summary

The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
2 countries

2 active sites

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

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
Last Updated

January 28, 2016

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

March 27, 2015

Last Update Submit

January 26, 2016

Conditions

Overweight and Obesity

Keywords

obesity,body weight,overweight,weight loss,polyglucosamine,L112caloric restrictionphysical activity

Outcome Measures

Primary Outcomes (1)

  • Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.

    24 weeks

Secondary Outcomes (3)

  • Change of body weight in kg

    24 weeks

  • Change of BMI

    24 weeks

  • Reduction of waist circumference

    24 weeks

Study Arms (2)

Medical device polyglucosamine

ACTIVE COMPARATOR

2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.

Device: Polyglucosamine

Placebo

PLACEBO COMPARATOR

2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.

Other: Placebo

Interventions

PolyglucosamineDEVICE

ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans

Medical device polyglucosamine
PlaceboOTHER

Placebo tablet

Placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 26 and \< 45
  • 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 and known hypersensitivity reactions to crustaceans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Salztal Klinik GmbH

Bad Soden-Salmünster, Hessia, 63628, Germany

Location

MAP Center

Rende, Cosenza, 87036, Italy

Location

Related Publications (1)

  • Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. BMC Obes. 2015 Jun 10;2:25. doi: 10.1186/s40608-015-0053-5. eCollection 2015.

    PMID: 26217540DERIVED

MeSH Terms

Conditions

OverweightObesityBody WeightWeight LossMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karina Pokhis, MD

    Salztal Klinik GmbH

    PRINCIPAL INVESTIGATOR

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

March 27, 2015

First Posted

April 8, 2015

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2010

Last Updated

January 28, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)IT(1)