Protocol summary
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Study aim
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The assessment of the effect of supplementation with Lactobacillus rhamnosus, Lactobacillus fermentum, and Lactobacillus plantarum on anthropometric indices, appetite, and serum level of Nesfatin, Omentin-1, LPS, liver function markers, metabolic parameters, oxidative stress, and inflammatory biomarkers in obese individuals
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Design
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A clinical trial with control group and four parallel groups of 25 obese people, randomized and triple blinded
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Settings and conduct
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Those who refer to Fardis Karaj laboratory are invited to participate in this study if they have the conditions to participate in the study and are willing to cooperate. People who signed the informed consent were randomly divided into the four mentioned groups. The supplements are prepared in the form of 1 gram powder sachets with similar packaging (for blinding) and with codes A to D, and people are requested to take 1 gram sachet daily before meals (mixed with water) for 2 Consume moon. At the beginning and end of the intervention, fasting blood sampling is done to determine the serum levels of the following biochemical variables in the amount of 6 cc.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Volunteer Obese people in the range of body mass index( 30≤BMI ≤ 40) aged 18-60 years.
Exclusion criteria: Allergy to probiotics; Having Diabetes, kidney disease, liver disease, and Thyroid disorders; Having a special diet to treat obesity in the last three months; Taking corticosteroids and/ or antibiotics; Regular Consumption of probiotics and/or nutritional supplements; Gastric surgery; pregnancy or lactation; Smoking and or drinking alcohol.
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Intervention groups
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Group1:Probiotic supplementation containing Lactobacillus fermentum (NCBI MT registration code 994667)
Group2: Probiotic supplementation containing Lactobacillus rhamnosus (NCBI MT registration code 995144)
Group3: Probiotic supplementation containing Lactobacillus plantarum (NCBI MT 012188)
Control group: Placebo as pure maltodextrin
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Main outcome variables
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Changes of anthropometric measurements, appetite, serum levels of nesfatin, omentin, Lipopolysaccharide (LPS,) metabolic markers, oxidative stress, and inflammatory marker
General information
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Reason for update
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Addition of some new parameters to the present project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220608055106N1
Registration date:
2022-07-03, 1401/04/12
Registration timing:
prospective
Last update:
2024-08-21, 1403/05/31
Update count:
1
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Registration date
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2022-07-03, 1401/04/12
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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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2022-07-23, 1401/05/01
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Expected recruitment end date
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2023-08-01, 1402/05/10
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Actual recruitment start date
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2022-10-23, 1401/08/01
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Actual recruitment end date
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2023-11-26, 1402/09/05
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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 supplementation with Lactobacillus rhamnosus, Lactobacillus fermentum, and Lactobacillus plantarum on anthropometric indices, appetite, and serum level of Nesfatin, Omentin-1, LPS, liver function markers, metabolic parameters, oxidative stress, and inflammatory biomarkers in obese individuals: a triple blinded RCT
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Public title
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Effect of probiotics supplementation in the control of obesity
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Obese people in the range of body mass index( 30≤BMI ≤ 40)
Age group of 18-60 years
Volunteers
Exclusion criteria:
Allergy to probiotics
Having Diabetes, kidney disease, liver disease, Thyroid disorders
Having a special diet to treat obesity in the last three months
Taking corticosteroids and/ or antibiotics
Regular Consumption of probiotics and/or nutritional supplements
Gastric surgery
Pregnancy. lactation
Smoking and or drinking alcohol
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
100
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization method with non-matched block size will be studied. For this purpose, a list of the order of allocation of samples by the second (non-original) researcher and using the software provided on the website https://www.sealedenvelope.com. Prepared and the size of the blocks will be two, four and six.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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After randomization, intervention groups 1 to 3 received powdered sachets containing isolated probiotics Lactobacillus rhamnus, fermentum, and plantarum, respectively, and group 4 received sachets containing maltodextrin as 1 sachet daily before the meal for 60 days. Sachets related to each group were prepared in similar and same-colored packages and provided to them monthly. For further blinding, the packaging of supplements and their coding (A-D) were done by someone outside of the project and other than the main researchers. The patient, doctors, statistical analyst, and the main researcher did not know those codes. After completing the study, the codes will be decoded.
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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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2022-05-21, 1401/02/31
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Ethics committee reference number
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IR.ABZUMS.REC.1401.054
2
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Ethics committee
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Approval date
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2024-07-08, 1403/04/18
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Ethics committee reference number
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IR.TBZMED.REC.1403.264
3
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Ethics committee
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Approval date
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2024-08-05, 1403/05/15
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Ethics committee reference number
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IR.TBZMED.REC.1403.361
4
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Ethics committee
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Approval date
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2024-08-05, 1403/05/15
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Ethics committee reference number
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IR.TBZMED.REC.1403.362
Health conditions studied
1
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Description of health condition studied
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Overweight and obesity
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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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Anthropometric indicators (height, weight, BMI, waist circumference)
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Weight scale, Meter
2
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Description
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Novel anthropometric indexes e.g., ABSI, BRI)
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Timepoint
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Weight scale, Meter
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Method of measurement
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Weight scale, Meter, related formula
3
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Description
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appetite
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Timepoint
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At first and end of two months intervention
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Method of measurement
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questionnaire
4
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Description
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Serum level of Nesfatin
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
5
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Description
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serum level of Omentin-1
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
6
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Description
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serum level of LPS
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
7
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Description
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Liver function test (ALT, AST, ALP)
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Auto-analyzer based on the principle of photometry
8
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Description
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FBS
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Auto-analyzer based on the principle of photometry
9
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Description
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serum Insulin
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
10
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Description
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lipid profile ( TC, TG, LDL.C, HDL.C)
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Auto-analyzer based on the principle of photometry
11
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Description
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MDA
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Spectrophotometer
12
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Description
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TAC
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
13
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Description
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TOC
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Timepoint
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At first and end of two months intervention
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Method of measurement
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Elisa kit
14
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Description
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CRP
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Timepoint
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At first and end of two months intervention
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Method of measurement
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photometry
15
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Description
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IL-6
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Timepoint
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At first and end of two months intervention
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Method of measurement
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ELISA KIT
16
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Description
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IL-1 B
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Timepoint
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At first and end of two months intervention
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Method of measurement
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ELISA KIT
17
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Description
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TNF alfa
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Timepoint
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At first and end of two months intervention
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Method of measurement
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ELISA KIT
Secondary outcomes
1
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Description
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Blood urea nitrogen
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Timepoint
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At first and end of two months intervention
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Method of measurement
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autoanalyzer
2
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Description
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CREATININ
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Timepoint
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At first and end of two months intervention
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Method of measurement
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autoanalyzer
Intervention groups
1
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Description
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Intervention group: (group1) Probiotic supplement in powder sacs containing Lactobacillus fermentum 014 NIMBB (NCBI MT registration code 994667) isolated from the ridge (for 60 days)
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Category
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Treatment - Drugs
2
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Description
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Intervention group:(Group2) Lactobacillus rhamnosus NIMBB006 (NCBI MT registration code 995144) isolated from breast milk at a rate of 2 * 10 cfu (for 60 days)
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Category
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Treatment - Drugs
3
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Description
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Intervention group ( Group3) Lactobacillus plantarum isolated from camel milk (cfu 9 10 * 2 NCBI MT 012188)(for 60 days)
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Category
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Treatment - Drugs
4
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Description
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Control group: Placebo with tasteless maltodextrin 100 for 60 days(for 60 days)
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Category
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Placebo
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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No
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Title of funding source
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Karaj University of Medical Sciences
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Proportion provided by this source
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30
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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
2
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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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Tabriz University of Medical Sciences
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Proportion provided by this source
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70
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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results publication
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When the data will become available and for how long
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After publishing the articles
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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with permission of the responsible members of the project
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From where data/document is obtainable
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Dr. Vahideh Ebrahimzadeh Attari, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, ebrahimzadeh.va@gmail.com
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What processes are involved for a request to access data/document
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please send an Email to: ebrahimzadeh.va@gmail.com
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Comments
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