Cholesterol LoweringNCT05038436
Influence of Polyglucosamine L112 on Serum Surrogate Markers of Cholesterol Absorption
A study testing Polyglucosamine L112 in people with Cholesterol Lowering, run by Certmedica International GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Lowering
- What is being tested?
- Polyglucosamine L112
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2021to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 41Show fewer
- 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
- Alkaline phosphatase not within normal range
- ALT/AST > 1.5xULN (upper normal limit)
- LDL cholesterol < 130 and >180 mg/dl
- Triglycerides > 200 mg/dl
- HbA1c > 6.5
- Campesterol in serum > 1 mg/dl
- Intake of food supplements (e.g. Becel Proactive)
- Contraindications for weight-reducing therapy
- Pure vegan diet
- Pure meat diet
- Diabetes mellitus type I and II
- Serious gastrointestinal diseases (ulcerative colitis, Crohn's disease, diverticulitis, short bowel syndrome, gastric ulcer, pronounced irritable bowel syndrome, reflux treated with medication, etc.) and after operations in the gastrointestinal tract (except: appendectomy)
- chronic digestive problems (constipation, constipation, etc.)
- Any other disease or medical treatment that, in the opinion of the investigator, could interfere with the assessment of safety, tolerability or efficacy.
- Current medication
- Lipid-lowering drugs such as statins, fibrates, ezitimib or PCSK9 inhibitors
- Interactions with polyglucosamine L112 are expected with the following medications: lipophilic oral medications such as cerebrally active drugs (including antiepileptics), lipophilic hormones (including the contraceptive pill), lipophilic antibiotics, digitalis, fat-soluble vitamins (A, D, E, K), (poly)unsaturated fatty acids.
- Exception: Participation in the study is possible if medicinal products for which an interaction is to be expected or cannot be ruled out can be taken at least 4 hours apart from polyglucosamine L112. I.e. since the test product must be taken with the main meals, participation in the study can only take place if it is not necessary to take it with the two main meals.
- taking proton pump inhibitors
- Long-term medication that reduces bowel activity (e.g. opiates)
- Subjects who are dependent on corticosteroids and who cannot be discontinued in time 10 days before the start of the study.
- Taking vitamin K antagonists or other anticoagulants
- Not taking stable medication that can lead to weight gain (e.g. certain neuroleptics, beta-blockers, psychotropic drugs)
- Taking orlistat
- Deliberate weight reduction >10 kg within the last 5 months
- Unintentional weight reduction within the last 5 months > 5 kg
Trial locations and contacts
1 site in 1 country.
Germany1 site
Phase I-Unit, Study Center Bonn (SZB), University Hospital Bonn
Bonn, North-Rhine Westfalia, 53227
About this study
Official title: Influence of a Medical Device (Polyglucosamine L112) on Serum Surrogate Markers of Cholesterol Absorption: a Prospective Placebo-controlled, Randomised, Double-blind Cross-over Study
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.
Read more
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.
Read the detailed description
In the present study, the influence of polyglucosamine L112 on cholesterol absorption in humans is to be investigated in more detail.
For this purpose, the subjects undergo two randomised study periods in a crossover design: first, there is a 2-week run-in phase, during which baseline values are collected without influence, then the subjects undergo two identical study periods, during which the subjects randomly take either polyglucosamine L112 or placebo twice a day. The study periods are separated by a two-week washout phase. After two weeks, a final examination takes place.
Throughout the course of the study, lipids in the serum are measured regularly. In order to examine cholesterol absorption, however, it is not sufficient to determine the cholesterol levels in the blood, as reduced absorption is physiologically compensated for by increased endogenous synthesis.
In the present study, the plant sterol campesterol, which is absorbed from the intestine like cholesterol, is determined as a surrogate marker for cholesterol absorption. At the same time, a surrogate marker for endogenous cholesterol synthesis is determined with lathosterol, which behaves like the endogenously synthesised cholesterol in terms of concentration. However, campesterol must also be set in relation to cholesterol via the campesterol-cholesterol quotient, since the concentration of campesterol is also dependent on the concentration of LDL lipoproteins as transport molecules, which reacts in the same way as the cholesterol concentration. Accordingly, a lower value of the campesterol-cholesterol quotient indicates reduced cholesterol absorption.
The values corrected for total cholesterol then give an overview of the endogenous cholesterol synthesis for the cholesterol precursors, that of the plant sterols via the cholesterol resorption rate in the small intestine and that of the oxysterols via the bile acid synthesis rate.
- Conditions
- Cholesterol Lowering
- Being tested
- Polyglucosamine L112
- Keywords
- obesity, weight reduction, cholesterol reduction
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglucosamine L112Device
Two tablets once daily per os
| Study group | Role | What they receive |
|---|---|---|
| Polyglucosamine L112 | Experimental | composed of (beta-1.4 polymer of D-glucosamine and N-acetyl-D-glucosamine) Receives: Device: Polyglucosamine L112 |
| Placebo | Placebo comparator | Dicalcium phosphate, cellulose Receives: Device: Polyglucosamine L112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of polyglucosamine L112 on dietary cholesterol absorption
Comparison of the campesterol-cholesterol quotient taking polyglucosamine L112 versus placebo
Measured: 10 weeks
Secondary outcomes (8)
Influence of polyglucosamine L112 on surrogate markers of cholesterol
Comparison of the ratio of sitosterol to cholesterol (cholesterol absorption)
Measured: 10 weeks
Influence of polyglucosamine L112 on cholesterol synthesis
Comparison of the ratio of lathosterol to cholesterol
Measured: 10 weeks
Influence of polyglucosamine L112 on bile acid synthesis
Comparison of the ratio of 7a- and 27-hydroxycholesterol to cholesterol
Measured: 10 weeks
Influence of polyglucosamine L112 on neutral fecal sterols
Comparison of the content of neutral sterols (cholesterol and bacterial degradation products coprostanol and coprostanone)
Measured: 10 weeks
Fecal primary and secondary bile acids
Comparison of the content of bile acids in the stool (cholic acid, deoxycholic acid, chenodeoxycholic acid, lithocholic acid and ursodeoxycholic acid)
Measured: 10 weeks
Cholesterol measurements
Comparison of total cholesterol (C), HDL-C, and LDL-C and triglycerides in serum
Measured: 10 weeks
Change in body weight
Comparison of body weight taking polyglucosamine L112 versus placebo
Measured: 10 weeks
Safety and tolerability (i.e. incidents of treatment-emergent adverse events) of polyglucosamine L112
Comparison of incidence of adverse events with polyglucosamine L112 versus placebo
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start16 Sep 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol LoweringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective, randomised, double blind, placebo controlled, 2 period crossover, monocenter
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Bonn
- Responsible party
- Sponsor
- Investigators
- Martin Coenen, MD, Principal investigator, University Hospital Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038436
- Sponsor's protocol ID
- EXT-202001
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Medical Device (Polyglucosamine L112) on Serum Surrogate Markers of Cholesterol Absorption: a Prospective Placebo-controlled, Randomised, Double-blind Cross-over Study
- ClinicalTrials.gov ID
- NCT05038436
- Acronym / sponsor ID
- EXT-202001
- Conditions
- Cholesterol Lowering
- Keywords
- obesity, weight reduction, cholesterol reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Bonn
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the present study, the influence of polyglucosamine L112 on cholesterol absorption in humans is to be investigated in more detail.
For this purpose, the subjects undergo two randomised study periods in a crossover design: first, there is a 2-week run-in phase, during which baseline values are collected without influence, then the subjects undergo two identical study periods, during which the subjects randomly take either polyglucosamine L112 or placebo twice a day. The study periods are separated by a two-week washout phase. After two weeks, a final examination takes place.
Throughout the course of the study, lipids in the serum are measured regularly. In order to examine cholesterol absorption, however, it is not sufficient to determine the cholesterol levels in the blood, as reduced absorption is physiologically compensated for by increased endogenous synthesis.
In the present study, the plant sterol campesterol, which is absorbed from the intestine like cholesterol, is determined as a surrogate marker for cholesterol absorption. At the same time, a surrogate marker for endogenous cholesterol synthesis is determined with lathosterol, which behaves like the endogenously synthesised cholesterol in terms of concentration. However, campesterol must also be set in relation to cholesterol via the campesterol-cholesterol quotient, since the concentration of campesterol is also dependent on the concentration of LDL lipoproteins as transport molecules, which reacts in the same way as the cholesterol concentration. Accordingly, a lower value of the campesterol-cholesterol quotient indicates reduced cholesterol absorption.
The values corrected for total cholesterol then give an overview of the endogenous cholesterol synthesis for the cholesterol precursors, that of the plant sterols via the cholesterol resorption rate in the small intestine and that of the oxysterols via the bile acid synthesis rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomised, double blind, placebo controlled, 2 period crossover, monocenter
| Arm | Type | Receives |
|---|---|---|
| Polyglucosamine L112 | Experimental | Device: Polyglucosamine L112composed of (beta-1.4 polymer of D-glucosamine and N-acetyl-D-glucosamine) |
| Placebo | Placebo comparator | Device: Polyglucosamine L112Dicalcium phosphate, cellulose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyglucosamine L112Two tablets once daily per os | Device | Placebo, Polyglucosamine L112 |
Primary outcome
Influence of polyglucosamine L112 on dietary cholesterol absorption
Time frame: 10 weeks
Comparison of the campesterol-cholesterol quotient taking polyglucosamine L112 versus placebo
8 secondary outcomes
Influence of polyglucosamine L112 on surrogate markers of cholesterol
Time frame: 10 weeks
Influence of polyglucosamine L112 on cholesterol synthesis
Time frame: 10 weeks
Influence of polyglucosamine L112 on bile acid synthesis
Time frame: 10 weeks
Influence of polyglucosamine L112 on neutral fecal sterols
Time frame: 10 weeks
Fecal primary and secondary bile acids
Time frame: 10 weeks
Cholesterol measurements
Time frame: 10 weeks
Change in body weight
Time frame: 10 weeks
Safety and tolerability (i.e. incidents of treatment-emergent adverse events) of polyglucosamine L112
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Coenen, MD principal investigator
University Hospital Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglucosamine L112 in people with Cholesterol Lowering, run by Certmedica International GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of polyglucosamine L112 on dietary cholesterol absorption (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.