MedTrace Logo

Influence of Polyglucosamine L112 on Serum Surrogate Markers of Cholesterol Absorption

NCT05038436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-18

No results posted yet for this study

Summary

Obesity is widespread and the number of overweight people has tripled from 1975 to 2016. According to the WHO (World Health Organisation), 1.9 billion adults worldwide are overweight, of which 650 million are obese. Thus, obesity is caused by a balance problem between the amount of food consumed and the energy used. The weighting of the diet in favour of a far too high fat intake also has a negative influence on the fat metabolism.

Obesity is associated with a number of secondary diseases, such as diabetes mellitus, increased inflammatory parameters in the blood and a higher risk of heart attack and stroke. These secondary diseases reduce the quality and duration of life of the person affected.

In animal studies, polyglucosamine was found to have a cholesterol-lowering effect. In human studies conducted over 3 and 12 months, formoline L112 was shown to lower LDL levels in the blood.

For research purposes, the present study will focus on investigating whether the intake of polyglucosamine L112 leads to a reduction in cholesterol intake from food, which should result in a reduced fat and thus calorie intake.

Conditions

  • Cholesterol Lowering

Interventions

DEVICE

Polyglucosamine L112

Two tablets once daily per os

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER

  • Certmedica International GmbH

    lead INDUSTRY

Principal Investigators

  • Martin Coenen, MD · University Hospital Bonn, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-06-21
Completion
2022-06-21

Countries

  • Germany

Study Locations

More Related Trials

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 NCT05038436 on ClinicalTrials.gov