Effects of probiotic supplementation with weight reducing plan on anthropometric measures, body composition, eating behavior, and related hormone levels in patients with food addiction and weight regain after bariatric surgery: A randomized clinical trial
Determining the effect of probiotic supplementation with weight loss diet and psychotherapy intervention on the improvement of food addiction and anthropometric indices in people with food addiction and weight regain after bariatric surgery
Design
A randomized, blinded, controlled clinical trial with a parallel group design of 50 patients, enrolled between may 2022 and September 2022
Settings and conduct
The study site is in the obesity clinic of Sina Hospital and the National Nutrition Research Institute. Study participants, researchers, intervention partners, data collectors, and data analysts are blind in this study.
All subjects received a diet and three sessions of psychotherapy intervention for three months, and two probiotic capsules per day in the intervention group and two placebo capsules per day in the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being in the age range of 18-50 years; At least 18 months have elapsed since the date of bariatric surgery and have a weight regain of at least 10% of the minimum weight gained; Confirmation of food addiction after obtaining the required score from the relevant questionnaire (YFAS)
Criteria for non-inclusion in the study: Pregnancy, lactation; professional athlete; Use of any antibiotics in the last three weeks; Use of any probiotic product or protein supplement in a recent month; Diseases of the liver (other than fatty liver), kidney, cancer and thyroid disease; Use of weight loss and appetite suppressants
Intervention groups
In this study, multi-strain probiotics were used for the intervention group and the control group receive a placebo capsule containing 300 mg of starch. The capsules are exactly the same in shape, size and color
Effects of probiotic supplementation with weight reducing plan on anthropometric measures, body composition, eating behavior, and related hormone levels in patients with food addiction and weight regain after bariatric surgery: A randomized clinical trial
Public title
effect of probiotic on food addiction and weight regain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Being in the age range of 18-50 years
At least 18 months have passed since the date of bariatric surgery and have a weight regain of at least 10% of the minimum weight gained
Confirmation of food addiction after obtaining the necessary points from the relevant questionnaire (YFAS)
Exclusion criteria:
Reluctance to cooperate in the study
Pregnancy, breastfeeding
professional athlete
Use of any antibiotics in the last three weeks
Use any probiotic product or protein supplement in a recent month
Liver disease (other than fatty liver), kidney, cancer and thyroid disease
Use of weight loss and appetite suppressants
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a Triple-blind Randomized Controlled Clinical Trial. A simple method has been used for randomization. Randomization unit is Individual. Excel software has been used for randomization.Using unique codes as ID numbers, using random numbers generated by the software, participants were randomly assigned to the same volume in the intervention and placebo groups.
(Description of randomization by Excel software: In the first step, we generated 50 random numbers according to the sample size, in the next step, we obtained the rank of these numbers obtained in the first step, in the third step, we divided these numbers by 25, in the fourth step, the numbers that fell between zero and one were in the intervention group and the rest in the placebo group)
The central service method was used for allocation concealment and someone outside our study performed allocation concealment and labeling of supplements.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Study participants, main study researchers, intervention and treatment partners, data collectors, and data analyzers were blinded in this study, and someone outside the study was used for randomization and labeling of probiotic and placebo supplements.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
Next to Ayatollah Taleghani Hospital, Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2022-02-19, 1400/11/30
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1400.099
Health conditions studied
1
Description of health condition studied
Food addiction, Weight regain after bariatric surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weight changes
Timepoint
At the beginning of the study and three months after the intervention
Method of measurement
Digital scale with an accuracy of 0.1 kg
2
Description
Food addiction
Timepoint
At the beginning of the study and three months after the intervention
Method of measurement
Yale Food Addiction Scale; YFAS
3
Description
Levels of the hormones leptin, serotonin and oxytocin
Timepoint
At the beginning of the study and three months after the intervention
Method of measurement
By ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Multi-strain probiotics were used. Each probiotic capsule contains Lactobacillus acidophilus (1.8 × 109 CFU / capsule), Bifidobacterium bifidum (1.8 × 109 CFU / capsule), Bifidobacterium lactis (1.8 × 109 CFU / capsule), Bifidobacterium longul / C, 1.8 (1 × 109 CFU / capsule), Lactobacillus reuteri (1 × 109 CFU / capsule), magnesium stearate and maltodextrin. participants take 2 capsules daily (after breakfast and after lunch) for 12 weeks. Prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol.
Category
Treatment - Other
2
Description
Control group: participants in the control group take two placebo capsules (after breakfast and lunch) daily for 12 weeks, containing 300 mg of starch. The capsules are completely similar in shape, size and color to the intervention capsules and are prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Country Nutrition Research Institute
Full name of responsible person
Atoosa Saidpour
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
atoosa.saidpour@gmail.com
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Atoosa Saidpour
Street address
Emam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
atoosa.saidpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atoosa Saidpour
Street address
Next to Taleghani Hospital; Yemen Street; Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 1021
Email
Atoosa.Saidpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atoosa Saidpour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
Atoosa.Saidpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atoosa Saidpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
Atoosa.Saidpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Ghafouri-Taleghani
Position
phd candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7425
Email
fatima.ghafouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Academic researchers and people working in industry
Under which criteria data/document could be used
In order to do research work or make medical products
From where data/document is obtainable
Send email to the Atoosa Saidpour ( Atoosa Saidpour@gmail.com)
What processes are involved for a request to access data/document
After sending the necessary documents to confirm the research or industrial project