Influence of Polyglucosamine L112 on Serum Surrogate Markers of Cholesterol Absorption

Launched by CERTMEDICA INTERNATIONAL GMBH · Sep 3, 2021

Keywords

ClinConnect Summary

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.

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • 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