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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824039
• Other study ID #: CEFMS 34/2019
• Status: Completed
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2023
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Faculty of Medicine of Sousse, 4000 Tunisia	Sousse

Sponsors (5)

Lead Sponsor	Collaborator
Laouani Aicha	Centre Hôpital Universitaire Farhat Hached, Faculty of Medicine, Sousse, Université de Sousse, University of Tsukuba

Country where clinical trial is conducted

Tunisia, 

References & Publications (7)

Boubaker J, Bhouri W, Ben Sghaier M, Ghedira K, Dijoux Franca MG, Chekir-Ghedira L. Ethyl acetate extract and its major constituent, isorhamnetin 3-O-rutinoside, from Nitraria retusa leaves, promote apoptosis of human myelogenous erythroleukaemia cells. Cell Prolif. 2011 Oct;44(5):453-61. doi: 10.1111/j.1365-2184.2011.00772.x. — View Citation

Boubaker J, Bhouri W, Sghaier MB, Bouhlel I, Skandrani I, Ghedira K, Chekir-Ghedira L. Leaf extracts from Nitraria retusa promote cell population growth of human cancer cells by inducing apoptosis. Cancer Cell Int. 2011 Oct 31;11(1):37. doi: 10.1186/1475-2867-11-37. — View Citation

Chaabane M, Koubaa M, Soudani N, Elwej A, Grati M, Jamoussi K, Boudawara T, Ellouze Chaabouni S, Zeghal N. Nitraria retusa fruit prevents penconazole-induced kidney injury in adult rats through modulation of oxidative stress and histopathological changes. Pharm Biol. 2017 Dec;55(1):1061-1073. doi: 10.1080/13880209.2016.1278455. — View Citation

Hashempur MH, Mosavat SH, Heydari M, Shams M. Medicinal plants' use among patients with dyslipidemia: an Iranian cross-sectional survey. J Complement Integr Med. 2018 Nov 3;16(3):/j/jcim.2019.16.issue-3/jcim-2018-0101/jcim-2018-0101.xml. doi: 10.1515/jcim-2018-0101. — View Citation

Rjeibi I, Feriani A, Hentati F, Hfaiedh N, Michaud P, Pierre G. Structural characterization of water-soluble polysaccharides from Nitraria retusa fruits and their antioxidant and hypolipidemic activities. Int J Biol Macromol. 2019 May 15;129:422-432. doi: 10.1016/j.ijbiomac.2019.02.049. Epub 2019 Feb 8. — View Citation

Zar Kalai F, Han J, Ksouri R, Abdelly C, Isoda H. Oral administration of Nitraria retusa ethanolic extract enhances hepatic lipid metabolism in db/db mice model 'BKS.Cg-Dock7(m)+/+ Lepr(db/)J' through the modulation of lipogenesis-lipolysis balance. Food Chem Toxicol. 2014 Oct;72:247-56. doi: 10.1016/j.fct.2014.07.029. Epub 2014 Jul 30. — View Citation

Zar Kalai F, Han J, Ksouri R, El Omri A, Abdelly C, Isoda H. Antiobesity Effects of an Edible Halophyte Nitraria retusa Forssk in 3T3-L1 Preadipocyte Differentiation and in C57B6J/L Mice Fed a High Fat Diet-Induced Obesity. Evid Based Complement Alternat Med. 2013;2013:368658. doi: 10.1155/2013/368658. Epub 2013 Dec 3. — View Citation

Outcome

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