Safety and Efficacy of Medicinal Plant Extract in Overweight and Obese Participants.

Study Overview
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Brief Summary
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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
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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)

Official Title
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Safety and Efficacy of the Short Daily Administration of Nitraria Retusa Extract in Overweight and Obese Participants. .

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Tea infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females age range of 18 and 75 years BMI >25 kg/ m^2 Exclusion Criteria: Hypertension Diabetes Asthma Smoking Professional athletic Pregnancy and breast feeding Participant with medical or psychiatric disorder or chronic pathology, Participant with eating disorder, food allergies. Participant with a history of cardiovascular disease, Participant with medication known to affect lipid metabolism, Participant with major gastrointestinal problems.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1: low dose group<br>Tea infusion which contain 5 mg of flavonoids, (low dose of flavonoids treatment quantification) oral administration , once daily. | Dietary Supplement: Tea infusion<br>* 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.<br>|
| Experimental: Experimental 2 : high dose group<br>Tea infusion which contain 20 mg of flavonoids, ( high dose of flavonoids Treatment quantification) oral administration , once daily . | Dietary Supplement: Tea infusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum Triglycerides (TG) levels | To evaluate the efficacy of 20 mg of flavonoids in reducing serum TG compared with low dose group ( 5 mg of flavonoids) after 10 days administration . | 10 days | 
| Change in serum High Density Lipoprotein Cholesterol (HDL-C) levels | To evaluate the efficacy of 20 mg of flavonoids in increasing HDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration | 10 days | 
| Change in Total Cholesterol ( TC) levels | To evaluate the efficacy of 20 mg of flavonoids in reducing TC levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration. | 10 days | 
| Change in Low Density Lipoprotein Cholesterol (LDL-C) levels | To evaluate the efficacy of 20 mg of flavonoids in reducing LDL-C levels compared with low dose group ( 5 mg of flavonoids) after 10 days administration | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no change from baseline in Alkaline phosphatase levels |  | 10 days | 
| no change from baseline in Aspartate aminotransferase levels. |  | 10 days | 
| no change from baseline in Alanine aminotransferase levels. |  | 10 days | 
| no change from baseline in gamma-glutamyltransferase levels. |  | 10 days | 
| no change from baseline in Albumin levels . |  | 10 days | 
| no change from baseline in total bilirubin levels |  | 10 days | 
| no change from baseline in direct bilirubin levels |  | 10 days | 
| no change from baseline in urea levels |  | 10 days | 
| no change from baseline in creatinine levels |  | 10 days | 
| no change from baseline in fasting blood glucose levels |  | 10 days | 
| no change from baseline in Red blood cells levels |  | 10 days | 
| no change from baseline in White blood cells levels |  | 10 days | 
| no change from baseline in Hemoglobin levels |  | 10 days | 
| no change from baseline in Hematocrit levels |  | 10 days | 
| no change from baseline in Platelets levels |  | 10 days | 
| no change from baseline in Hemodynamic indicators: heart rate and blood pressure : systolic blood pressure and diastolic blood pressure |  | 10 days | 
| Adverse events | Adverse events reported | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medicinal plants, Anti-lipidimic agents, Infusion