Evaluation of Libramed in Obesity Treatment
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Randomized, double-blind, placebo-controlled study aimed at evaluating the effects of a
      3-months treatment with Policaptil Gel Retard on postprandial incretin hormones release and
      satiety in obese women
    

Detailed description: 
      Double-blind, randomized, placebo-controlled, parallel-group study.

      This study will in made of 3 phases:

        -  The assessment of standard dose (3 tablets) of Libramed or placebo on the incretin
           hormones release and satiety sensation in obese women after ingestion of four test meal
           administered with one day interval - run-in period, to assess incretin hormones release
           and satiety sensation in obese women

        -  A double-blind phase in which the treament with Libramed/Placebo will be administered
           for 3 months.

        -  A post (3-months) treatment assessment of the incretin hormones release and satiety
           sensation after ingestion of four test meals - follow-up period.

      During the screening visit (V1, Week -1) patients will be evaluated with regard to the
      inclusion and exclusion criteria that will permit their entry into the run-in period. The
      results of the laboratory analyses such as lipids, glucose and insulin levels needed to check
      subjects' eligibility at the time of randomization [baseline visit (V2)] will be performed at
      the screening visit. The run-in period starts on day 2 of the menstrual cycle and ends not
      later than 12 days of menstrual cycle.

      During the four visits of run-in period (V2, V3, V4 and V5) will be assessed the effect of
      double-blind single dose of Libramed or placebo on postprandial incretin axis activity,
      glucose and triglycerides levels, satiety feeling and subsequent food consumption in relation
      to macronutrients content in test meals intake. During the visit V2 patient will be trained
      on diary completion.

      On the first visit of this period (V5) patient previously randomized on the first visit of
      the run-in period (V2) will receive the first kit of Libramed or placebo. Each patient will
      self-administer 3 tablets of Libramed or placebo 2 times per day 15 minutes before breakfast
      and lunch. The dose of Libramed or placebo will be stable during the treatment period.

      During the visit V5 patient will be trained on the Libramed or placebo self-administration,
      patient's diary completion and on diet and physical activity recommendation.

      The follow-up period includes four visits (from V9 to V12), in the week immediately after the
      last intake of Libramed or placebo. The first visit of the follow-up period (V9) will take
      place the day immediately after the last intake of Libramed or placebo. The visits 9 to 12
      (V9, V10, V11, V12) will take place with one day interval from each other, during the week
      after the last dose of Libramed or placebo use. On these visits the test meals will be
      administered and postprandial incretin axis, glucose and triglycerides levels as well as
      satiety feeling will be assessed.
    

Intervention name(s): Libramed; Placebo
Intervention type(s): Device; Device
Other intervention name(s): Policaptil gel retard; Placebo-comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Libramed; Policaptil Gel retard; Overweigth; Obesity; Medical Device; glycemic profile; incretin