Influence of Polyglucosamine L112 on Serum Surrogate Markers of Cholesterol Absorption

NCT05038436 | Completed

• 1 other identifier: EXT-202001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obesity; weight reduction; cholesterol reduction

Outcome Measures

Primary Outcomes (1)

• Influence of polyglucosamine L112 on dietary cholesterol absorption

  Comparison of the campesterol-cholesterol quotient taking polyglucosamine L112 versus placebo

  10 weeks

Secondary Outcomes (8)

• Influence of polyglucosamine L112 on surrogate markers of cholesterol

  10 weeks

• Influence of polyglucosamine L112 on cholesterol synthesis

  10 weeks

• Influence of polyglucosamine L112 on bile acid synthesis

  10 weeks

• Influence of polyglucosamine L112 on neutral fecal sterols

  10 weeks

• Fecal primary and secondary bile acids

  10 weeks

Study Arms (2)

Polyglucosamine L112

EXPERIMENTAL

composed of (beta-1.4 polymer of D-glucosamine and N-acetyl-D-glucosamine)

Device: Polyglucosamine L112

Placebo

PLACEBO COMPARATOR

Dicalcium phosphate, cellulose

Device: Polyglucosamine L112

Interventions

Polyglucosamine L112 DEVICE

Two tablets once daily per os

Placebo; Polyglucosamine L112

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be ≥ 18 years and ≤ 65 years of age at the time of the screening examination.
• Written documented informed consent and consent to participate in the study.
• Body weight must be ≥ 75 kg at the time of the screening examination.
• Balanced omnivorous diet
• Subjects who are able to follow study instructions and are likely to attend all required study visits (compliance)
• Women of childbearing age must use a reliable method of contraception during treatment
• Negative pregnancy test

You may not qualify if:

• BMI \< 20 and \> 30
• Subject is unable to understand the scope, significance and consequences of this clinical trial
• known hypersensitivity to crustaceans or any of the ingredients of polyglucosamine L112
• concurrent participation in another clinical trial or participation in a clinical trial involving the use of an investigational product for up to 30 days prior to participation in this trial
• known or suspected abuse of medications, drugs, or alcohol
• existing or planned pregnancy or lactation
• not using any contraceptive measure
• previous or active malignant disease
• liver or kidney dysfunction
• history of or clinical evidence of heart failure
• History of lactose intolerance
• Serum laboratory parameters:
• TSH not within normal range
• Creatinine not within normal range
• Bilirubin not within normal range

Sponsors & Collaborators

• Certmedica International GmbH: lead
• University Hospital, Bonn: collaborator

Study Sites (1)

Phase I-Unit, Study Center Bonn (SZB), University Hospital Bonn

Bonn, North-Rhine Westfalia, 53227, Germany

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Martin Coenen, MD

  University Hospital Bonn, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial product (verum and placebo) is labelled and packaged by an authorised body according to randomisation, so that there is only specific numbering according to randomisation on the otherwise identical-looking packs. An emergency envelope, located at the study centre, can be used to unblind in an emergency by the principal investigator or investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomised, double blind, placebo controlled, 2 period crossover, monocenter

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: September 16, 2021
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)