Safety and Efficacy of Medicinal Plant Extract in Overweight and Obese Participants.
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this randomized , double -blind clinical trial is to evaluate the efficacy and
      safety of a daily administration of Nitraria retusa extract in overweight and obese
      participants, during 10 days.
    

Detailed description: 
      Medicinal plants are widely used for their accessibility, safety and effectiveness and may be
      an excellent alternative strategy for developing future drugs with minor adverse effects.
      Several studies concerning the potential of bioactive components in plants and food products
      and their link to many diseases including, diabetes, cardiovascular disease and obesity.

      Nitraria retusa is a salt-tolerant plant that belongs to the Nitrariaceae family. It is
      particularly distributed in Asia, China, North Africa, Russia and Europe.It grows in the
      southern part of Tunisia and it is locally known as Ghardaq. The leaves serve as supplement
      for the tea and are used as poultice. Fresh leaves of Nitraria retusa have been used in
      traditional medicine in case of poisoning, upset stomach, ulcers, gastritis, enteritis,
      heartburn, colitis, and colonic abdominal pain.

      Moreover, anticancer, antioxidant, antiviral and antimicrobial activities of N. retusa have
      been reported .Several reports evinced that the leaf of Nitraria retusa contains high amounts
      of tannins, alkaloids, steroids and flavonoids, which could be responsible for its beneficial
      effects . Previous studies have demonstrated the effect of Nitraria retusa extract in obese
      mice against high fat diet through lowering glucose and triglycerides and the enhancement of
      the lipid metabolism in liver.

      The purpose of this study was to evaluate the efficacy and safety of short daily
      administration of Nitraria retusa extract in lipid profile in overweight and obese patients,
      during 10 days.

      This study will be carried out in 2 departments: the laboratory of biophysics of the Faculty
      of Medicine of Sousse and Endocrinology and diabetology of CHU Farhat Hached Sousse ,Tunisia.
      At day 0 and day 10 all the population will benifit of biological assessment which include:

        -  Biochimical parameters

             -  Complete lipid profile (Total Cholesterol (T-C), High-density Lipoprotein (HDL)
                Low-density Lipoprotein (LDL) and Triglycerides( TG) .

             -  Blood sugar

             -  Liver Function Test : Alkaline phosphatase (ALP), gamma-glutamyltransferase (G-GT),
                albumin, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total (
                TB) and direct bilirubin (DB).

             -  Renal Function Test : Serum Creatinine, urea

             -  Inflammatory assessment: Reactive protein C

        -  Hematological parameters : (Red blood cells (RBC), White blood cell (WBC), Platelet,
           Hemoglobin and Hematocrit).

      All Population will be randomized :Participant will be assigned to one of two treatments (low
      dose flavonoids or high dose flavonoids ). The diatry supplement :Nitraria retusa infusion
      will be prescribed at a quantity of powder which contained 5 mg of flavonoids or which
      contained 20 mg of flavonoids , added to 100 ml of boiling water and will be taken once a day
      at a bed time for 10 consecutive days.

      Statistical analysis Data entry and analysis will be performed using SPSS 22.0 for
      Windows(IBM Corp., NY, USA ). Results will be considered significant at p < 0.05 Normal
      distributions of the data will be assessed by Shapiro-Wilk test. Within-group differences in
      the biological parameters before and after the intervention will be compared using paired
      t-test when data are normally distributed and Wilcoxon Signed Rank Test when data are not
      normaly distrubuted. Between-group differences (low dose vs high dose) in the parameters will
      be assessed by independent samples t-test (parametric and equal variances), Welch's t-test
      (unequal variances) and Mann-Whitney U test (nonparametric)
    

Intervention name(s): Tea infusion
Intervention type(s): Dietary Supplement
Intervention description(s): Tea infusion: The aerial parts of the medicinal plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. The powder was added to 100 ml of boiling water and the tea infusion was taken once time a day at the bed time and it was repeated for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Medicinal plants; Anti-lipidimic agents; Infusion