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The Effect of Probiotics Supplementation on Expression of Osteoprotegerin and Receptor Activator of Nuclear Factor Kappa Beta Ligand Genes, Serum Levels of C- terminal Telopeptide of Type I Collagen and Osteocalcin, Anthropometric Indices, Body Composition, and Quality of Life After Sleeve Gastrectomy: A Randomised Controlled Clinical Trial

Protocol summary

Study aim
Determining and comparing the effect of probiotic supplementation on the expression of osteoprotegerin and receptor activator of nuclear factor kappa beta ligand genes, serum levels of C- terminal telopeptide of type I collagen, and osteocalcin, anthropometric indices, body composition, quality of life, and gastrointestinal symptoms in people with gastric sleeve surgery
Design
A double-blind randomized controlled trial, phase 3 with 36 patients, randomization with RAND excel function
Settings and conduct
Patients referring to clinics affiliated to Tabriz University of Medical Sciences will be included in the study using easy sampling. Patients will be randomly divided into two groups. The researcher and the patients will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obese patients undergoing laparoscopic gastric sleeve operation. Age over 18 years. Willingness to cooperate in the study Exclusion criteria: consumption of antibiotics, probiotic supplements, and/or foods enriched with probiotics. Immunosuppressant treatment before study entry. Infection.
Intervention groups
Supplementation with probiotics (intervention group) and placebo (control group) will be done from the second week after surgery for 12 weeks. The blood sample will be analyzed to evaluate the expression of genes and the serum level of the target markers before and after the intervention. Also, anthropometric information, demographic, quality of life, and digestive symptoms questionnaires will be completed before and after the intervention..
Main outcome variables
Expression of Osteoprotegerin and Receptor Activator of Nuclear Factor Kappa Beta Ligand Genes, Serum Levels of C- terminal Telopeptide of Type I Collagen and Osteocalcin, Anthropometric Indices, Body Composition, and Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240115060696N1
Registration date: 2024-03-26, 1403/01/07
Registration timing: prospective

Last update: 2024-03-26, 1403/01/07
Update count: 0
Registration date
2024-03-26, 1403/01/07
Registrant information
Name
Fatemeh Hamedi-kalajahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 109 2867
Email address
fatemehamedi2018@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-21, 1403/02/02
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Probiotics Supplementation on Expression of Osteoprotegerin and Receptor Activator of Nuclear Factor Kappa Beta Ligand Genes, Serum Levels of C- terminal Telopeptide of Type I Collagen and Osteocalcin, Anthropometric Indices, Body Composition, and Quality of Life After Sleeve Gastrectomy: A Randomised Controlled Clinical Trial
Public title
The Effect of Probiotics Supplementation on Expression of Osteoprotegerin and Receptor Activator of Nuclear Factor Kappa Beta Ligand Genes, Serum Levels of C- terminal Telopeptide of Type I Collagen and Osteocalcin, Anthropometric Indices, Body Composition, and Quality of Life After Sleeve Gastrectomy: A Randomised Controlled Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Obese patients undergoing gastric sleeve laparoscopic surgery. Age above 18 years. Willingness to cooperate in the study.
Exclusion criteria:
Antibiotics treatment. Consuming probiotic supplements and/or probiotic-enriched foods. Immunosuppressant treatment before study entry. Infection.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
(Stratified blocked) randomization, individual, computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
All the cans containing supplements and placebo will be coded with numbers 1 or 2 by someone outside the study, and people will be assigned to one of the groups receiving code 1 or 2 based on the blocks. As a result, the researcher and the patients will be blinded.
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Gholgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.TBZMED.REC.1402.749

Health conditions studied

1

Description of health condition studied
Bone disorders
ICD-10 code
M85.9
ICD-10 code description
Disorder of bone density and structure, unspecified

2

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

3

Description of health condition studied
Gastrointestinal symptoms
ICD-10 code
K92.9
ICD-10 code description
Disease of digestive system, unspecified

Primary outcomes

1

Description
gene expression of Osteoprotegerin
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
Real-time PCR

2

Description
gene expression of Receptor Activator of Nuclear Factor Kappa Beta Ligand
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
Real-time PCR

3

Description
serum level of osteocalcin
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
ELISA

4

Description
serum level of C- terminal Telopeptide of Type I Collagen
Timepoint
Before the start of the intervention and 3 months after the intervention
Method of measurement
ELISA

5

Description
quality of life
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
questionnare

6

Description
Anthropometric index(weight, height, and Body Mass Index)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Analogue scale

7

Description
Body composition
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Body analyzer

Secondary outcomes

1

Description
Gastrointestinal symptoms
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Intervention group will receive daily 1 capsule of probiotics supplement for 12 weeks. Probiotics will be purchased from the Zist Takhmir Company. All the patients will be monitored for consumption of probiotics by weekly checklists and recall messages
Category
Prevention

2

Description
Intervention group: Intervention group will receive daily 1 capsule of placebo supplement for 12 weeks. Placebos will be purchased from the Zist Takhmir Company. All the patients will be monitored for consumption of placebos by weekly checklists and recall messages
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh Al Rais clinic affiliated to Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Hamedi-Kalajahi
Street address
Golgasht Street, Sheikh Al Rais Building
City
Tabriz
Province
East Azarbaijan
Postal code
000000
Phone
+98 914 109 2867
Email
fatemehamedi2018@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Street address
Golgasht Street, Tabriz university of Medical sciences, Food and Nutrition Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
0000000
Phone
+98 914 189 4102
Email
mdalizadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Hamedi-Kalajahi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
TABRIZ, GOLGASHT ST., FACULTY OF FOOD AND NUTRITION SCIENCES, TABRIZ UNIVERSITY OF MEDICAL SCIENCES
City
Tabriz
Province
East Azarbaijan
Postal code
5351749319
Phone
+98 41 3441 7843
Email
fatemehamedi2018@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Hamedi-Kalajahi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
TABRIZ, GOLGASHT ST., FACULTY OF FOOD AND NUTRITION SCIENCES, TABRIZ UNIVERSITY OF MEDICAL SCIENCES
City
Tabriz
Province
East Azarbaijan
Postal code
5351749319
Phone
+98 41 3441 7843
Email
fatemehamedi2018@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Hamedi-Kalajahi
Position
PhD student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food sciences, Tabriz University of Medical Sciences, Attar Neishabouri St., Tabriz, Iran
City
East Azerbaijan
Province
East Azarbaijan
Postal code
00000000
Phone
+98 41 3441 7843
Email
fatemehamedi2018@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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