Influence of Polyglucosamine L112 on Serum Surrogate Markers of Cholesterol Absorption
Condition: Cholesterol Lowering
Study type: Interventional

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.
    

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.
    

Intervention name(s): Polyglucosamine L112
Intervention type(s): Device
Intervention description(s): Two tablets once daily per os
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospective, randomised, double blind, placebo controlled, 2 period crossover, monocenter
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: obesity; weight reduction; cholesterol reduction