Protocol summary

Study aim
Determining the effect of yogurt containing probiotics and exercise on muscle mass, muscle strength, anthropometric and biochemical indices and gastrointestinal quality of life in patients after bariatric surgery.
Design
This study is a randomized, double-blinded, controlled clinical trial with four parallel groups (3 intervention and one control groups). 52 individuals (13 in each group) were randomized into groups with balanced-blocked randomization.
Settings and conduct
52 eligible individuals referred to Hafez and Ghadir hospital,Shiraz, after becoming informed and obtaining informed consent, will be randomly assigned into 4 study groups.They receive yogurt and exercise program according to their group.The yogurt bottles named the same as the groups with the letters A, B to blind the participant and the researcher and they take it daily for 8 weeks. Body composition, muscle strenght, anthropometric and biochemichal indices and gastrointestinal quality of life score will be assessed before and after the study
Participants/Inclusion and exclusion criteria
Inclusion: Age over 18 years and being candidate for bariatric surgery, absence of disease or special sensitivity Exclusion: unwillingness to continue cooperation for any reason or any complications after the operation, not following interventions and suffering from disease or infection
Intervention groups
1. Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 8 weeks along with resistance training program 2. Receiving 120 cc of yogurt containing the desired probiotics for a period of 8 weeks 3. Receive 120 cc of plain low-fat yogurt for 8 weeks along with resistance training program 4. Receiving 120 cc of plain low-fat yogurt for 8 weeks as a control group
Main outcome variables
muscle mass , muscle strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231231060581N1
Registration date: 2024-01-08, 1402/10/18
Registration timing: prospective

Last update: 2024-01-08, 1402/10/18
Update count: 0
Registration date
2024-01-08, 1402/10/18
Registrant information
Name
Shirin Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3636 3326
Email address
sh_rajabi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt and exercise on the muscle mass, muscle strength, anthropometry and biochemical parameters and GI quality of life in post-bariatric surgery patients
Public title
Investigating the effect of probiotics and exercise in patients after bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bariatric surgery candidate Age above 18
Exclusion criteria:
Having cardiovascular disorders, systolic or diastolic blood pressure, uncontrolled metabolic disorders, neuromuscular or rheumatological disorders, acute pulmonary embolism, chronic symptomatic heart failure, mental or physical disabilities Sensitivity to milk protein and lactose Sensitivity to gluten Taking nutritional supplements, prebiotics and probiotics since 1 month before entering the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will perform using the random block method (1: 1: 1:1 ratio) for four groups (one control and three intervention groups). In this method, blocks of four with rotation will be created by an out-of-study person. Then, a block will be randomly selected to determine the groups assigned to the first four participants. The random-blocks selection process will be repeated to determine the random allocation for the entire sample size. For allocation concealment, after determining the random sequence, these sequences will be placed in numbered sealed opaqued envelopes for each participant. An out-of-study person familiar with randomization will perform this process. During the study, by entering any participant in the study, based on the sequence, an envelope will be opened and the allocated group will be revealed
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, for blinding the interventions, enriched yogurts and placebo are the same in terms of color, odor, and taste and will be named A and B. The process of filling yogurt containers and naming them will be done by an out-of-study person. Therefore, in this study, the research team and the participants of different groups will be blinded to the type of the interventions or placebo consumed by each participant in order to observe the principles of blinding. For the exercise intervention group, the program is designed individually and home-based and the participants are not aware about each other's intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Health and Nutrition-Shiraz University of Medical Sciences
Street address
School of Health and Nutrition, Razi Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.SUMS.MED.REC.1402.421

Health conditions studied

1

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

Primary outcomes

1

Description
muscle mass
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Body Analyzer

2

Description
muscle strength
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
handgrip, sit to stand test

3

Description
weight
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
scale

4

Description
BMI
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
formula

5

Description
(%EWL
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
formula

6

Description
body fat percent
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
body analyzer

7

Description
waist circumference
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
flexible meter

8

Description
hip circumference
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
flexible meter

9

Description
waist/hip ratio
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
formula

10

Description
waist/height ratio
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
formula

11

Description
triglyceride
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

12

Description
total cholestrol
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

13

Description
LDL (low-density lipoprotein)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

14

Description
HDL (high-density lipoprotein)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

15

Description
fasting blood sugar (FBS)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

16

Description
Alanine transaminase (ALT)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

17

Description
Aspartate transaminase (AST)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

18

Description
GGT(Gammaglutamyl transferase)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
colorimetric method

19

Description
malondialdehyde (MDA)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
spectrophotometry

20

Description
Insulin
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA) kit

21

Description
cortisol
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA) kit

22

Description
testostron
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA) kit

23

Description
CRP(C-reactive Protein)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA) kit

24

Description
Adiponectin
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA) kit

25

Description
vitamin d3
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
HPLC

26

Description
Gastrointestinal quality of life questionnaire score
Timepoint
At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 8 weeks along with a resistance training program
Category
Treatment - Other

2

Description
Intervention group: Receiving 120 cc of yogurt containing the desired probiotics for a period of 8 weeks
Category
Treatment - Other

3

Description
Intervention group: Receive 120 cc of plain low-fat yogurt for 8 weeks along with a resistance training program
Category
Treatment - Other

4

Description
Control group: Receive 120 cc of plain low-fat yogurt for 8 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Siavash Babajafari
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
۳۴۷۸۶-۷۱۹۴۶
Phone
+98 71 3647 9531
Email
jafaris@sums.ac.ir

2

Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Siavash Babajafari
Street address
Gloshan Town
City
Shiraz
Province
Fars
Postal code
۷۱۴۴۹۹۵۳۷۷
Phone
+98 71 3227 9701
Email
jafaris@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Siavash Babajafari
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
jafaris@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 8099
Email
shirin_r69@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
siavash babajafari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 8099
Email
jafaris@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3481 4336
Email
shirin_r69@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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