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.: PACTR202210705998795 Date of Approval: 03/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of prebiotic and probiotic supplementation on Weight Loss, psychological profile and metabolic parameters in obese subjects
Official scientific title Effects of prebiotic and probiotic supplementation on Weight Loss, psychological profile and metabolic parameters in obese subjects
Brief summary describing the background and objectives of the trial Today, the microbiota is considered a therapeutic revolution, where researchers use its enrichment to prevent or treat certain diseases including obesity , such as fecal transplantation , but also the enrichment of the microbiota by prebiotics and probiotics to treat obesity. Hence our interest in transposing these theoretical results to clinical practice. The objective of this interventional clinical trial was to evaluate the effects of a probiotic supplement containing bifidobacteruim, lactobacillus strains and a prebiotic supplement by carob on the changes in body composition and metabolic biomarkers in subjects with obesity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 29/09/2022
Actual Last follow-up date 29/09/2022
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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 Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group prebiotics and probiotics in obesity 1 month Fourty five patients were recruited at their first visit to the obesity unit (T0) and were randomly assigned to three groups matched for age, sex and BMI. • Group on low-calorie diet alone (15 patients) called “diet only” • 15 patients on the same diet plan but additionally received prebiotic supplementation (2 carob beans/day about 30 g) called “prebiotic group”. • Low-calorie diet group with probiotic supplementation, n=15. The probiotic component used in the study contained a blend (one capsule contained which is an association of 4 microbiological strains which are: bifidobacteruim longum, lactobacillus helveticus, lactococcus lactis, streptococcus thermophilus (1 tablet (10.10⁹UFC/capsule)/day) called “probiotic group”. The probiotic supplement was produced by Pileje Labs. 15 Uncontrolled
Control Group prebiotics and probiotics in obesity 1 month control group will be the group on diet only 15 Active-Treatment of Control Group
Experimental Group on probiotic 1 month 1 pill of probiotic a day 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
We included in our study obese patients (BMI ≥ 30 kg/m²) aged over 18 years. Patients with: renal failure, hypothyroidism, cancer, diabetic patients on insulin, on long-term corticosteroid therapy, former patients of the obesity unit were not included. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 28/02/2022 comit dethique de linstitut national de nutrition de tunis
Ethics Committee Address
Street address City Postal code Country
11 rue jbal lakhdher tunis 1170 Tunisia
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 28/05/2022 commite dethique de linstitut national de nutrition de tunis
Ethics Committee Address
Street address City Postal code Country
11 rue jballakhdher tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome weight loss after 1 month
Secondary Outcome other anthropometric parameters 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
institut national de nutrition et de technologie alimentaire de tunis 11 rue jbal lakhdhar tunis Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
principal investigator 11 rue jbal lakhdher tunis tunis Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor none 11 rue jbal lakhdhar tunis Tunisia there is no sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rym ben othman benothmanr@gmail.com +21699907402 residence aicha laouina
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
Role Name Email Phone Street address
Public Enquiries henda jamoussi hendajamoussi@gmail.com +21698648225 11 rue jbal lakhdher
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
Role Name Email Phone Street address
Scientific Enquiries ramla mizouri mizouri.ramla@gmail.com +21693787431 11 rue jbal lakhdher
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes i can share my results by an excess document wich will be shared via email when asked Clinical Study Report 1 year controlled
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