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.: PACTR202202746907105 Date of Approval: 21/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fiber supplementation in obesity
Official scientific title Eeffect of fiber supplementation on insulin resistance in obese children and adolescents
Brief summary describing the background and objectives of the trial With increase prevalance of obesity and its complications as metabolic syndrome and type 2 DM, there is a high need to control obesity and prevent such complications Diet modification was used but high fiber is still a new modality that need to be explorated.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/01/2020
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group fiber suplementation for 8 weeks intervention divided to 2 groups first from natural high diet fiber about 15 to 30 gm second from psylium husks 10 gm once daily 60
Control Group fiber supplementation 10 weeks regular diet and lifestyle 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children and adolescents 6-15years both sexes exogenous obesity BMI >+2 ZSCORE normal height patients with known endocrinal disorders patient with syndromic obesity patient on drugs causing overweight subjects with co -morbidities except of insulin resistance Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 15 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 07/08/2019 The research Ethics Committee of the faculty of medicine of cairo university
Ethics Committee Address
Street address City Postal code Country
Fourth Floor Administration Building Facalty of Medicine - Cairo University Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of fiber supplementation on insulin resistance in obese children and adolescents. after 8 weeks.
Secondary Outcome effect of fiber supplementation on weight after 8 weeks and 10 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
clinical nutrition outpatient clinic Abu el RISH hospital cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
kits and psyliium cairo cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Sedkey marwasedkey@cu.edu.eg 00201145712208 Giza
City Postal code Country Position/Affiliation
Giza Egypt assistant lecturer of pediatrics in cairo university
Role Name Email Phone Street address
Public Enquiries Marwa Sedkey marwasedkey@cu.edu.eg 00201145712208 Giza
City Postal code Country Position/Affiliation
Giza Egypt assistant lecturer of pediatrics in Cairo university
Role Name Email Phone Street address
Scientific Enquiries Marwa Sedkey marwasedkey@cu.edu.eg 00201145712208 Giza
City Postal code Country Position/Affiliation
Giza Egypt assistant lecturer of pediatrics in cairo university
Role Name Email Phone Street address
Scientific Enquiries Hannah Aboulghar haboulghar@gmail.com 001001439192 cairo
City Postal code Country Position/Affiliation
cairo Egypt professor of pediatrics in Cairo university
Role Name Email Phone Street address
Scientific Enquiries Hend Soliman ziad.alaa@yahoo.com 0020143156468 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt professor of pediatrics in Cairo university
Role Name Email Phone Street address
Scientific Enquiries Shrouk Sayed shroukmoataz14@gmail.com 00201205551828 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of pediatrics in Cairo university
Role Name Email Phone Street address
Scientific Enquiries Radwa Abdel Halim radwa.marawan@kasralainy.edu.eg 01281235123 cairo
City Postal code Country Position/Affiliation
cairo Egypt lecturer of chemical pathology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication with Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose
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