Policaptil Gel Retard® in Overweight and Mild Obese Subjects
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is a randomized, double blind, placebo controlled, interventional clinical study aimed
      at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the
      glycemic, lipid and weight profile in overweight and mild obese subjects
    

Detailed description: 
      This is a randomized, double blind, placebo controlled, interventional clinical study on a
      medical device Visit schedule V1 (day -25) - Screening Visit During this visit (V1) the
      Investigator will collect information regarding the medical history, the demography, the
      concomitant medications. The eligibility criteria (inclusion and exclusion criteria) will be
      verified and during this visit the subjects who will meet the eligibility criteria will be
      enrolled after the signature of the informed consent form. Each subject will be informed
      verbally and in writing about the nature and all the requirements of the study.

      A brief clinical examination will be performed, including evaluation of vital signs (pulse,
      systolic and diastolic pressure) and anthropometric parameters (body weight, height, BMI,
      waist circumference, waist-to-hip and waist-to-height ratio).

      Blood and urine samples will be collected for safety routine analysis and for specific
      analysis to test liver and kidney functionality, glycemic and lipid profile (i.e. glycemic /
      lipid markers values). An Oral Glucose Tolerance Test (OGTT) will be also performed.

      A diary will be given to each subject to record their daily food intake (they will be asked
      to avoid some food and food supplements/ingredients) and physical activity.

      The next visit will be scheduled after 15 days. V2 (day -10) - postprandial metabolic profile
      short-term assessment - Policaptil Gel Retard® intake During this visit the Investigators
      will perform a brief clinical examination evaluating pulse, systolic and diastolic pressure
      and anthropometric parameters; a confirmation of eligibility will take place, on the basis of
      laboratory tests results.

      A blood sample will be collected (t0) and then, after the intake of a standard dosage of
      Libramed®, a standard meal will be supplied. In order to record the postprandial metabolic
      profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300
      minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and
      lipid profile.

      For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate
      VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU). This analysis will be
      performed at Clinica Medica I, Azienda Ospedaliera di Padova.

      Information on adverse events and concomitant medications will be collected and recorded by
      the investigators.

      The subjective appetite will be assessed using 100mm VASs that will have to be completed
      before Libramed®, before meal and 150 minutes after consumption of meal.

      The next visit will be scheduled after 10 days. V3 (day 0) - postprandial metabolic profile
      short-term assessment - placebo and baseline / randomization During this visit the
      Investigators will perform a brief clinical examination evaluating pulse, systolic and
      diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique)
      will be also evaluated.

      A blood sample will be collected (t0) and then, after the intake of a standard dosage of
      placebo, a standard meal will be supplied. In order to record the postprandial metabolic
      profile blood samples will be collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300
      minutes after the meal (t1, 2, 3, 4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and
      lipid profile.

      For the first 10 subjects enrolled additional 2 ml of blood will be collected to evaluate
      VLDL, IDL, LDL, HDL by Density Gradient Ultracentrifugation (DGU).

      Moreover a blood sample will be collected in the fasting state for specific analysis to test
      liver and kidney functionality.

      The subjective appetite will be assessed using 100mm VASs that will have to be completed
      before Libramed® or placebo, before meal and 150 minutes after consumption of meal.

      All eligible subjects will be randomized to Policaptil Gel Retard® or placebo and a diet to
      be followed will be given and explained by a dietitian to all the participants. The daily
      dietary intake of participants during the intervention period will be set to 1200, 1500 or
      1800 Kcal/day depending on the nutritional need of each participant (basal energy
      expenditure), calculated by means of the Harris Benedict equation (see the protocol for
      details). They will be asked also to make a daily walk (7000-10000 steps average, to be
      counted by a pedometer that they will be given too).

      The subjects will be given enough study product, according to randomization, to reach the
      following visit. Moreover a new diary will be given to each subject and the old one will be
      collected.

      Information on adverse events and concomitant medications will be collected and recorded by
      the investigators.

      The next visit will be scheduled after 30 days. V4 (day 30) - end of treatment visit and
      postprandial metabolic profile long-term assessment - treatment During this visit the
      Investigators will perform a brief clinical examination evaluating pulse, systolic and
      diastolic pressure and anthropometric parameters; whole-body fat mass (through DXA technique)
      will be also evaluated.

      A blood sample will be collected (t0) and then, after the intake of a standard dosage of
      placebo or Policaptil Gel Retard®, according to randomization, a standard meal will be
      supplied. In order to record the postprandial metabolic profile blood samples will be
      collected 8 times: 30, 60, 90, 120, 150, 180, 240 and 300 minutes after the meal (t1, 2, 3,
      4, 5, 6, 7 and 8) to evaluate the postprandial glycemic and lipid profile. Moreover blood
      samples will be collected in the fasting state for specific analysis to test liver and kidney
      functionality, for safety routine analysis (also urine sample) and for specific analysis to
      test liver and kidney functionality.

      The subjective appetite will be assessed using 100mm VASs that will have to be completed
      before Libramed® or placebo, before meal and 150 minutes after consumption of meal.

      Information on adverse events and concomitant medications will be collected and recorded by
      the investigators.

      The diaries and all the unused or empty containers of the study products will have to be
      brought back to the center, in order to evaluate the subject's adherence to the treatment.

      A phone call will be scheduled after 7 days. Follow-up (day 37) A phone contact will take
      place to assess the safety profile (AE/SAE will be evaluated). Information on concomitant
      medications and a confirmation about dietary restrictions will be collected and recorded.
    

Intervention name(s): Libramed; Placebo
Intervention type(s): Device; Device
Intervention description(s): Policaptil Gel Retard; Placebo-comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Libramed; Policaptil Gel Retard; Overweight; Obesity; Medical Device; glycemic profile; lipid profile