NCT05824039

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 11, 2023

Last Update Submit

April 21, 2023

Conditions

OverweightObesity

Keywords

Medicinal plantsAnti-lipidimic agentsInfusion

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (17)

  • 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

  • +12 more secondary outcomes

Study Arms (2)

Experimental 1: low dose group

EXPERIMENTAL

Tea infusion which contain 5 mg of flavonoids, (low dose of flavonoids treatment quantification) oral administration , once daily.

Dietary Supplement: Tea infusion

Experimental 2 : high dose group

EXPERIMENTAL

Tea infusion which contain 20 mg of flavonoids, ( high dose of flavonoids Treatment quantification) oral administration , once daily .

Dietary Supplement: Tea infusion

Interventions

Tea infusionDIETARY_SUPPLEMENT

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 1: low dose groupExperimental 2 : high dose group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • age range of 18 and 75 years
  • BMI \>25 kg/ m\^2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Sousse, 4000 Tunisia

Sousse, 4002, Tunisia

Location

Related 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.

    PMID: 21951288BACKGROUND

  • 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.

    PMID: 22040460BACKGROUND

  • 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.

    PMID: 28198206BACKGROUND

  • 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.

    PMID: 30391934BACKGROUND

  • 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.

    PMID: 25086370BACKGROUND

  • 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.

    PMID: 30742925BACKGROUND

  • 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.

    PMID: 24367387BACKGROUND

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor PHD, Head of the common Services unit for Research , biophysics Laboratory

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 21, 2023

Study Start

March 20, 2021

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)