Protocol summary
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Study aim
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Determining the effect of yogurt containing probiotics and exercise on muscle mass, muscle strength, anthropometric and biochemical indices and depression score in patients after bariatric surgery.
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Design
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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.
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Settings and conduct
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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 12 weeks. Body composition, muscle strenght, anthropometric and biochemichal indices and depression score will be assessed before and after the study
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Participants/Inclusion and exclusion criteria
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Inclusion: Age over 18 years and post- bariatric surgery patients, 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
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Intervention groups
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1. Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 12 weeks along with resistance training program 2. Receiving 120 cc of yogurt containing the desired probiotics for a period of 12 weeks 3. Receive 120 cc of plain low-fat yogurt for 12 weeks along with resistance training program 4. Receiving 120 cc of plain low-fat yogurt for 12 weeks as a control group
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Main outcome variables
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muscle mass , muscle strength
General information
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Reason for update
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Change in the type of questionnaire in the title due to the greater importance of depression factor in these people based on studies/Editing inclusion and exclusion criteria/
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231231060581N1
Registration date:
2024-01-08, 1402/10/18
Registration timing:
prospective
Last update:
2026-02-11, 1404/11/22
Update count:
1
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Registration date
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2024-01-08, 1402/10/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-02-20, 1402/12/01
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Expected recruitment end date
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2024-07-20, 1403/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of probiotic yogurt and exercise on the muscle mass, muscle strength, anthropometry and biochemical parameters and depression score in post-bariatric surgery patients
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Public title
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Investigating the effect of probiotics and exercise in patients after bariatric surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
post-bariatric surgery patients
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 prebiotics and probiotics since 1 month before entering the study
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-12-31, 1402/10/10
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Ethics committee reference number
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IR.SUMS.MED.REC.1402.421
Health conditions studied
1
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Description of health condition studied
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obesity, bariatric surgery
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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muscle mass
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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Body Analyzer
2
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Description
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muscle strength
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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handgrip, sit to stand test
3
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Description
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weight
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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scale
4
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Description
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BMI
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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formula
5
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Description
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body fat percent
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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body analyzer
6
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Description
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waist circumference
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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flexible meter
7
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Description
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hip circumference
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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flexible meter
8
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Description
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waist/hip ratio
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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formula
9
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Description
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waist/hip ratio
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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formula
10
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Description
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triglyceride
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
11
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Description
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total cholestrol
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
12
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Description
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LDL (low-density lipoprotein)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
13
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Description
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HDL (high-density lipoprotein)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
14
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Description
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fasting blood sugar (FBS)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
15
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Description
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Alanine transaminase (ALT)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
16
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Description
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Aspartate transaminase (AST)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
17
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Description
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GGT(Gammaglutamyl transferase)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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colorimetric method
18
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Description
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malondialdehyde (MDA)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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spectrophotometry
19
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Description
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Insulin
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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Enzyme-linked immuno_sorbent assay (ELISA) kit
20
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Description
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cortisol
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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Enzyme-linked immuno_sorbent assay (ELISA) kit
21
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Description
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hs-CRP(C-reactive Protein)
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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Enzyme-linked immuno_sorbent assay (ELISA) kit
22
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Description
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Adiponectin
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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Enzyme-linked immuno_sorbent assay (ELISA) kit
23
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Description
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vitamin d3
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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HPLC
24
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Description
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depression score
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Timepoint
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At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
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Method of measurement
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questionnaire
Intervention groups
1
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Description
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Intervention group: Receiving 120 cc of low-fat yogurt containing Bacillus coagulans + Lactobacillus plantarum probiotics in the amount of 1010 bacteria per day for 12 weeks along with a resistance training program
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Category
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Treatment - Other
2
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Description
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Intervention group: Receiving 120 cc of yogurt containing the desired probiotics for a period of 12 weeks
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Category
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Treatment - Other
3
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Description
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Intervention group: Receive 120 cc of plain low-fat yogurt for 12 weeks along with a resistance training program
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Category
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Treatment - Other
4
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Description
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Control group: Receive 120 cc of plain low-fat yogurt for 12 weeks
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available