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.: PACTR201803003172179 Date of Registration: 07/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oro-gustatory perception of dietary lipids, a factor of increase of obesity in adults in Morocco: from sensation to genetic polymorphism
Official scientific title The alteration of oro-gustatory detection of fatty acids (oleic acid), genetic polymorphism increase the risk of obesity in adult Moroccan subjects
Brief summary describing the background and objectives of the trial The sensitivity to the oral fatty acid taste contributes to the development of obesity. Several large studies have demonstrated the ability of humans and rodents to detect long chain fatty acids (LCFA), contained in their diet as gustatory cues, via lipid receptors such as CD36 (cluster of differentiation 36) and GPR120, a G-protein-coupled receptor, that are involved in the spontaneous preference for dietary lipids. It has also been established that a genetic polymorphism of such receptors may influence oral detection thresholds of lipids among some obese subjects. The objective of our study is to investigate the implication of genetic polymorphism in the development of obesity and to determine its role in gustatory perception of fatty acid (oleic acid) in obese and lean Moroccans adults.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/10/2015
Actual trial start date 05/10/2015
Anticipated date of last follow up 31/10/2016
Actual Last follow-up date 31/10/2016
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 135
Recruitment status Completed
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oro-gustatory detection of oleic acid 4ml 5min The studied subjects were divided into two groups: obese (case) so that the BMI (body mass index: index designed for each subject as a body weight in kg divided by height in m2) was ¿30 kg/m2 and lean (control) where the BMI was inserted between 19 and 24.9 kg/m2 (in accordance with the recommendations of the World Health Organization). They were exposed to an examination of dietary lipids taste p 75
Experimental Group blood sampling 4ml for genetic analyzes and 4ml for biological analyzes 1min blood sampling will be carried out by a team of doctors and nurses honed to this activity in accordance with good laboratory practice 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Adult subjects (age¿18years); ¿ Consenting; ¿ Two sex: male and female; ¿ BMI: body mass index (superior than 30 kg/m2 for the obese group and between 19 and 24.9 kg/m2 for the lean one); ¿ Preferably, non-smokers and not suffering from chronic pathologies; ¿ Subjects suffering from chronic illnesses (diabetes, hypertension, cardiovascular diseases¿); ¿ Smokers; ¿ Pregnant, lactating and/or menopausal women; ¿ Patients undergoing treatment (known to affect taste); ¿ Subjects from the same family; ¿ Mentally/physically handicapped people; ¿ Subjects refusing to participate. 18 Year(s) 58 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 21/04/2015 Ethics Committee for Biomedical Research (Faculty of Medicine and Pharmacy-Mohammed 5th University-Rabat).
Ethics Committee Address
Street address City Postal code Country
Mohamed Belarbi El Alaoui Rabat 6203 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Oleic acid detection threshold the moment of the test
Secondary Outcome absence or oresence of genotyping (CD36/GPR120) After starting and performing genetic analyzes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nutrition Unit, Hygiene and Collectivity Medicine Ward-Military Hospital of Instruction Mohammed 5th (M.H.I.M.5, Rabat-Morocco) Hay Ryad RABAT, avenue des FAR Rabat 10100 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
awn resources of the laboratory of the Joint Unit of Nutrition and Food Research (URAC39).CNESTEN. Ibn Tofaïl University.Kenitra.Morocco Avenue de L'Université, Campus Universitaire, BP 133 Kenitra 14000 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Joint Unit of Nutrition and Food Research (URAC39).CNESTEN. Ibn Tofaïl University.Kenitra.Morocco Avenue de L'Université, Campus Universitaire, BP 133 Kenitra 14000 Morocco University
COLLABORATORS
Name Street address City Postal code Country
Pr Hasnae BENKIRANE Campus Universitaire, BP 133, Kénitra Kenitra 14000 Morocco
Pr Hassan AGUENAOU Campus Universitaire, BP 133, Kénitra Kenitra 14000 Morocco
Pr Naim Akhtar KHAN Recteur Marcel Bouchard, Maison de l'université, Esplanade Erasme, 21078 Dijon Dijon 21000 France
Pr Youness TABOZ Campus Universitaire, BP 133, Kénitra Kenitra 14000 Morocco
Pr Rabea ZIRI Campus Universitaire, BP 133, Kénitra Kenitra 14000 Morocco
Dr Khalid ELKARI Campus Universitaire, BP 133, Kénitra Kenitra 14000 Morocco
Pr Mustapha Mrabet Avenue Mohammed Belarabi Elalaoui Rabat Institut, 6203, Rabat Rabat 10100 Morocco
Pr Jaafar HEIKEL Rue Tarik Ibnou Ziad, B.P. 9154,Quartier: les Hôpitaux casablanca Casablanca 20360 Morocco
Dr Hakim BELGHITI Hay Ryad RABAT, avenue des FAR,Nutrition Unit- Military Hospital of Instruction Mohammed 5th Rabat 10100 Morocco
Dr Hakim BELGHITI Hay Ryad RABAT, avenue des FAR,Nutrition Unit- Military Hospital of Instruction Mohammed 5th Rabat 10100 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hakim Belghiti hakbelg@yahoo.fr +212661064034 Hay Ryad RABAT, Avenues des FAR - Nutrition Unit Militiary Hospital of Insturction Mohammed 5th
City Postal code Country Position/Affiliation
Rabat 10100 Morocco Nutritionist docotr at Nutrition Unit - Miliatary Hospital of Instruction Mohammed 5h
Role Name Email Phone Street address
Public Enquiries Hassan Agenaou agenaou2014@gmail.com +212663756730 Ave de L'Université,Campus Universitaire, BP 133 kénitra-Faculty of science-Ibn Tofai Univ
City Postal code Country Position/Affiliation
Kenitra 14000 Morocco PhD. Joint Res Unit Nutrition Food. Faculty of science-Ibn Tofaïl Univ
Role Name Email Phone Street address
Scientific Enquiries Hanae Benkirane hbenkianeer555@gmail.com +212661040402 Ave de L'Université,Campus Universitaire, BP 133 kénitra-Faculty of science-Ibn Tofai Univ
City Postal code Country Position/Affiliation
Kenitra 14000 Morocco PhD. Joint Res Unit Nutrition Food. Faculty of science-Ibn Tofaïl Univ
REPORTING
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