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

April 21, 2023 updated by: Laouani Aicha

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4002
        • Faculty of Medicine of Sousse, 4000 Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laouani Aicha

Collaborators

Faculty of Medicine, Sousse
Centre Hôpital Universitaire Farhat Hached
University of Tsukuba
Université de Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Actual)

April 8, 2022

Study Completion (Actual)

April 8, 2022

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEFMS 34/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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