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Trial registered on ANZCTR
Registration number
ACTRN12622000696796
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
13/05/2022
Date last updated
10/03/2024
Date data sharing statement initially provided
13/05/2022
Date results information initially provided
10/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Impact of probiotics and octacosanol supplementation on the regulation of obesity and associated diseases in overweight and obese women in the reproductive period
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Scientific title
Evaluation of the synergistic effect of a new probiotic concept and octacosanol in the treatment of obesity and associated comorbidities in overweight and obese women
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Secondary ID [1]
306885
0
This research is part of the project "Assessing the potential of a new concept of dietary supplement containing probiotics in the treatment of obesity and associated comorbidities" registered by Ministry of Education, Science and Technological Development of the Republic of Serbia. Number of project: 451-03-02141/2017-09/35
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
325983
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Condition category
Condition code
Diet and Nutrition
323298
323298
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study will be conducted as a randomized, double-blind, placebo-controlled study. Intervention group will receive 1 oral capsule once a day for 3 months containing 7x10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5x10^9 CFU Saccharomyces cerevisiae var. boulardii and 40 mg octacosanol.
Patients will be given dietary supplement by the Master of pharmacy, at the beginning of the study, in the form of oral capsules, which will contain listed probiotic strains and octacosanol, in an amount sufficient for 3 months (90 capsules). Patients will take dietary supplements at their home. Adherence to the intervention will be monitored by the number of returned capsules.
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Intervention code [1]
323342
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Treatment: Other
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Comparator / control treatment
Control group (placebo-maltodextrin capsule)
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Control group
Placebo
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Outcomes
Primary outcome [1]
331029
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Change of anthropometric parameters:
body weight - using scale with bioelectrical impedance analysis technology
body height- using stadiometer
body mass index - using scale with bioelectrical impedance analysis technology
waist and hip circumference - using a tape measure
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Assessment method [1]
331029
0
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Timepoint [1]
331029
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90 days after intervention commencement
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Primary outcome [2]
331030
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Changes of biochemical parameters (lipid status, glucose, hemoglobin A1c and insulin levels) - serum/plasma assay
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Assessment method [2]
331030
0
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Timepoint [2]
331030
0
90 days after intervention commencement
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Primary outcome [3]
331031
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Changes of inflammatory parameters (interleukin-6, interleukin-17, tumor necrosis factor-alpha, C-reactive protein)-serum/plasma assay
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Assessment method [3]
331031
0
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Timepoint [3]
331031
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90 days after intervention commencement
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Secondary outcome [1]
408542
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Changes in the composition of the fecal microbiota - feces assay
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Assessment method [1]
408542
0
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Timepoint [1]
408542
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90 days after intervention commencement
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Secondary outcome [2]
409146
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leukocyte typing - flow cytometry (serum/plasma assay)
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Assessment method [2]
409146
0
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Timepoint [2]
409146
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90 days after intervention commencement
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Secondary outcome [3]
409147
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changes in epigenetics - PCR (blood sample)
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Assessment method [3]
409147
0
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Timepoint [3]
409147
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90 days after intervention commencement
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Secondary outcome [4]
409148
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side effects - adverse events were assessed by interviews with participants at the end of intervention period, and they were recorded on the adverse event form throughout the study. The participants were asked to self-report any health-related problems or symptoms they were experiencing during the intervention period.
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Assessment method [4]
409148
0
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Timepoint [4]
409148
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90 days after intervention commencement
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Secondary outcome [5]
409149
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changes in dietary habits - 72-hour dietary recall questionnaire
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Assessment method [5]
409149
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Timepoint [5]
409149
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90 days after intervention commencement
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Eligibility
Key inclusion criteria
Overweight and obese women (body mass index > 25 kg/m^2) with or without other comorbidities (hypertension, dyslipidemia,hyperglycemia and/or insulin resistance)
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Chronic disease of the kidneys, thyroid gland and gastrointestinal tract (Crohn's disease, ulcerative colitis)
Taking antibiotic therapy in the last month
Age under 18 years
Taking probiotic and/or prebiotic dietary supplements
Hypersensitivity/intolerance to any ingredient of the product
Pregnancy or breast-feeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by numbered containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method used to create the random order for the allocation of subjects into different groups was simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
10/06/2020
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Date of last participant enrolment
Anticipated
6/07/2022
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Actual
6/07/2022
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Date of last data collection
Anticipated
6/10/2022
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Actual
12/10/2022
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Sample size
Target
60
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Accrual to date
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Final
55
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Recruitment outside Australia
Country [1]
24716
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Serbia and Montenegro
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State/province [1]
24716
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Serbia
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Funding & Sponsors
Funding source category [1]
311196
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University
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Name [1]
311196
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Faculty of Pharmacy, University of Belgrade
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Address [1]
311196
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Vojvode Stepe 450, Belgrade 11221, Serbia
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Country [1]
311196
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Serbia and Montenegro
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Primary sponsor type
University
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Name
Faculty of Pharmacy, University of Belgrade
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Address
Vojvode Stepe 450, Belgrade 11221, Serbia
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Country
Serbia and Montenegro
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Secondary sponsor category [1]
312572
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None
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Name [1]
312572
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Address [1]
312572
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Country [1]
312572
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Other collaborator category [1]
282245
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Hospital
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Name [1]
282245
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Clinical Center of Serbia, Department of Endocrinology, Diabetes and Metabolic Diseases, Belgrade, Serbia
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Address [1]
282245
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Dr Subotica 13, Belgrade 11000, Serbia
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Country [1]
282245
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Serbia and Montenegro
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310728
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Ethics committee, Clinical Center of Serbia
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Ethics committee address [1]
310728
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Pasterova 2, Belgrade 11000, Serbia
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Ethics committee country [1]
310728
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Serbia and Montenegro
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Date submitted for ethics approval [1]
310728
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Approval date [1]
310728
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21/02/2019
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Ethics approval number [1]
310728
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31/28
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Summary
Brief summary
Numerous studies have shown that obesity may be associated with changes in the bacterial flora in the gut and that the composition of the intestinal microbiota differs in obese and normally weight individuals. Therefore, the use of dietary supplements with beneficial cultures of microorganisms, probiotics, and biologically active compounds, such as octacosanol, are increasingly considered a rational choice as part of dietary interventions in the treatment of obesity. Our study intends to evaluate the impact of a combination of two probiotic strains and octacosanol in overweight and obese women in the reproductive age.
This study will be conducted as a randomized, double-blind, placebo-controlled study, where patients are going to be divided in two groups: the first group of patients (intervention group) will receive 1 oral capsule once a day for 3 months containing 7x10^10 CFU Lactobacillus plantarum 299v (DSM9843), 5x10^9 CFU Saccharomyces cerevisiae var. boulardii and 40 mg octacosanol, and another group of patients (control group) who will receive 1 oral capsule once a day for 3 months containing placebo. The aim of this study is to assess the effect of probiotics and octacosanol on anthropometric parameters, biochemical parameters (lipid status, glucose level, etc.), inflammatory parameters, epigenetics, changes in intestinal microbiota, as well as the effect on changes in the immune system (leukocyte typing), in overweight and obese women.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
118662
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Prof Brižita Ðordevic
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Address
118662
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Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
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Country
118662
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Serbia and Montenegro
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Phone
118662
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+38163245062
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Fax
118662
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Email
118662
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[email protected]
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Contact person for public queries
Name
118663
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Mrs Nevena Ivanovic
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Address
118663
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Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
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Country
118663
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Serbia and Montenegro
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Phone
118663
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+381652358892
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Fax
118663
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Email
118663
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[email protected]
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Contact person for scientific queries
Name
118664
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Mrs Nevena Ivanovic
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Address
118664
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Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
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Country
118664
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Serbia and Montenegro
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Phone
118664
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+381652358892
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Fax
118664
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Email
118664
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Protection of private data.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15734
Ethical approval
383901-(Uploaded-09-04-2022-20-11-32)-Study-related document.pdf
15735
Informed consent form
383901-(Uploaded-09-04-2022-23-21-36)-Study-related document.doc
15736
Other
Lifestyle questionnaire
383901-(Uploaded-09-04-2022-23-26-52)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Okuka, N.; Schuh, V.; Krammer, U.; Polovina, S.; S...
[
More Details
]
383901-(Uploaded-23-01-2024-23-54-03)-Journal results publication.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF