Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205671550114 Date of Approval: 11/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pilot Study of Laurus nobilis Tea on Oxidant/Antioxidant Stress Biomarkers in Healthy North-African Volunteers
Official scientific title Randomized, Placebo-Controlled Pilot Study of Laurus nobilis Tea on Oxidant/Antioxidant Stress Biomarkers in Healthy North-African Volunteers
Brief summary describing the background and objectives of the trial BACKGROUND Laurus nobilis (Ln) is an evergreen tree of the family Lauraceae, commonly used for culinary and medicinal purposes. It is thought to have its origin in the Mediterranean region and in Asia. In North Africa, this plant is a common species, and in Tunisia, it is called "Rand". “Rand’ is particularly widespread in Tunisia by the riversides, on mountains, and on wet cliffs. A previous study demonstrated that Laurus nobilis has high levels of chemical compounds possessing antioxidant activities, such as scavenging activity. It was hypothesized that consumption of Laurus nobilis tea (Lnt) infusion would lead to great benefits, reflected by changes in peripheral biomarkers. In addition, it was found that consumption of dried aqueous extracts of Ln improves glucose and insulin metabolism as well as circulating blood lipids in patients with type 2 diabetes-mellitus. Moreover, according to traditional medicine, Ln is widely used as a medicinal plant in the treatment of several diseases, in particular against respiratory, diabetic and digestive disorders. In this context, and according to the Tunisian tradition, Ln is most often used in the form of an infusion obtained from the fresh or dried plant. To the best of the authors’ knowledge, there is no scientific data highlighting the therapeutic effects of Lnt infusion on healthy humans, and particularly its impacts on the blood lipid and oxidant-antioxidant data. Such properties are interesting in the prevention of cardiovascular diseases. Numerous randomized trials have demonstrated that low-density lipoprotein cholesterol (LDL-cholesterol) levels reduce the risk of cardiovascular events by upregulation of the low-density lipoprotein (LDL) receptor (LDL-R). The LDL-R is the primary pathway for removal of cholesterol from the circulation, and its activity is meticulously governed by intracellular cholesterol levels. Studies showed that the LDL-R internalized LDL-cholesterol from plasma leading to release of cholesterol into the cell which appeared to be responsible for the feedback inhibition of 3-hydroxy3-methylglutaryl coenzyme A reductase (HMG-CoA reductase). In the general population reduced LDL-R activity frequently contributes to hypercholesterolemia which over time, contributes to the development of atherosclerosis. In biology, oxidation reactions can also damage various components of cells. This oxidative damage is associated with aging and certain diseases, such as cardiovascular ones. OBJECTIVES. The purpose of this randomized, double-blind controlled trial, which includes two groups [Experimental group (EG), control group (CG)], was to investigate the effects of Lnt consumption on oxidant/antioxidant and lipid data in humans. The null hypothesis was that the two groups will have similar LDL-R values, 10 days after the intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Lnt
Disease(s) or condition(s) being studied Cardiology,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/05/2022
Actual trial start date 04/05/2022
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date 31/05/2022
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 55
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laurus nobilis tea Five grams of dried Laurus nobilis tea leaves in 100 ml of boiling water for 15 min 10 days Five grams of dried Laurus nobilis tea leaves in 100 ml of boiling water for 15 min, and to filter the mixture through a strainer. 31
Control Group Origanum syriacum L 5 grams 10 days The placebo material will be prepared from the hard stems of Origanum syriacum L. Stems will be cleaned and boiled for five hours, with water change every one hour. Prolonged boiling will be performed to make the stems with a very poor content of water-soluble components 31 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
no smoking no vegetarian diet no pregnancy no consumption of medication or nutritional supplements no chronic pathologies (eg; cardiovascular diseases, diabetes-mellitus, arterial-hypertension, asthma, psychiatric disorders, gastrointestinal problems) no food allergy. Absence during the second visit (ie; Day11 of the study) Non-consumption of the Laurus nobilis tea at least one time Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 28 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2022 Medical Research and Ethical Committee at the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Street Mohamed KAROUI Sousse 4000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome low-density lipoprotein (LDL) receptor (LDL-R) 10 days
Secondary Outcome CP: Carbonylated proteins HDL-C: High-density lipoprotein cholesterol LDL-C: Low-density lipoprotein cholesterol SOD: Superoxide dismutase TC: Total cholesterol TG: Triglycerides UA: Uric acid 10 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Farhat Hached Street Ibn Eljazzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Laboratory of Biochemistry Faculty of Medicine Sousse Mohamed Karoui street Sousse 4000 Tunisia
Metabolic Biophysics and Applied Pharmacology Research Laboratory Mohamed Karoui Sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory of Biochemistry Ibn Eljazzar Sousse 4000 Tunisia Hospital
Secondary Sponsor Metabolic Biophysics Applied Pharmacology Laboratory Mohamed Karoui street Sousse 4000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
ChahraCHBILI Mohamed Karoui street Sousse 4000 Tunisia
Maher MAOUA Mohamed Karoui street Sousse 4000 Tunisia
Sawssen MRAD Mohamed Karoui street Sousse 4000 Tunisia
Mejda SELMI Mohamed Karoui street Sousse 4000 Tunisia
Hajer GRAEIT Mohamed Karoui street Sousse 4000 Tunisia
Jihen MAATOUG Mohamed Karoui street Sousse 4000 Tunisia
Lamia ABDELLAOUI Mohamed Karoui street Sousse 4000 Tunisia
Nejib MRIZEK Mohamed Karoui street Sousse 4000 Tunisia
Manel NOUIRA Mohamed Karoui street Sousse 4000 Tunisia
Maha BEN FREDJ Mohamed Karoui street Sousse 4000 Tunisia
Helmi BEN SAAD Mohamed Karoui street Sousse 4000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chahra CHBILI chahrachbili@yahoo.fr +21693645001 Mohamed Karoui street
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Metabolic Biophysics Applied Pharmacology Laboratory
Role Name Email Phone Street address
Scientific Enquiries Helmi BEN SAAD helmi.bensaad@rns.tn +21698697024 Mohamed Karoui street
City Postal code Country Position/Affiliation
sousse 4000 Tunisia Reasearch laboratory Heart failure LR12SP09
Role Name Email Phone Street address
Public Enquiries Chahra CHBILI chahrachbili@yahoo.fr +21693645001 Mohamed Karoui street
City Postal code Country Position/Affiliation
sousse 4000 Tunisia Metabolic Biophysics Applied Pharmacology Laboratory
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available and collected during the trial after deidenfication. All of the individual participant data collected during the trial, after deidentification. Study protocol, Informed Consent Form will be available. The data will be available immediately following final publication. Ending 2 years following article publication. The data will be available with researchers who provide a methodologically sound proposition to achieve aims into the proposed proposal. Proposals should be directed to chahrachbili@yahoo.fr Informed Consent Form,Study Protocol 12 months Laurus nobilis Tea
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information