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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
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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 325983 0
Condition category
Condition code
Diet and Nutrition 323298 323298 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323342 0
Treatment: Other
Comparator / control treatment
Control group (placebo-maltodextrin capsule)
Control group
Placebo

Outcomes
Primary outcome [1] 331029 0
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
Timepoint [1] 331029 0
90 days after intervention commencement
Primary outcome [2] 331030 0
Changes of biochemical parameters (lipid status, glucose, hemoglobin A1c and insulin levels) - serum/plasma assay
Timepoint [2] 331030 0
90 days after intervention commencement
Primary outcome [3] 331031 0
Changes of inflammatory parameters (interleukin-6, interleukin-17, tumor necrosis factor-alpha, C-reactive protein)-serum/plasma assay
Timepoint [3] 331031 0
90 days after intervention commencement
Secondary outcome [1] 408542 0
Changes in the composition of the fecal microbiota - feces assay
Timepoint [1] 408542 0
90 days after intervention commencement
Secondary outcome [2] 409146 0
leukocyte typing - flow cytometry (serum/plasma assay)
Timepoint [2] 409146 0
90 days after intervention commencement
Secondary outcome [3] 409147 0
changes in epigenetics - PCR (blood sample)
Timepoint [3] 409147 0
90 days after intervention commencement
Secondary outcome [4] 409148 0
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.
Timepoint [4] 409148 0
90 days after intervention commencement
Secondary outcome [5] 409149 0
changes in dietary habits - 72-hour dietary recall questionnaire
Timepoint [5] 409149 0
90 days after intervention commencement

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)
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by numbered containers.
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.
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2020
Date of last participant enrolment
Anticipated
6/07/2022
Actual
6/07/2022
Date of last data collection
Anticipated
6/10/2022
Actual
12/10/2022
Sample size
Target
60
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 24716 0
Serbia and Montenegro
State/province [1] 24716 0
Serbia

Funding & Sponsors
Funding source category [1] 311196 0
University
Name [1] 311196 0
Faculty of Pharmacy, University of Belgrade
Country [1] 311196 0
Serbia and Montenegro
Primary sponsor type
University
Name
Faculty of Pharmacy, University of Belgrade
Address
Vojvode Stepe 450, Belgrade 11221, Serbia
Country
Serbia and Montenegro
Secondary sponsor category [1] 312572 0
None
Name [1] 312572 0
Address [1] 312572 0
Country [1] 312572 0
Other collaborator category [1] 282245 0
Hospital
Name [1] 282245 0
Clinical Center of Serbia, Department of Endocrinology, Diabetes and Metabolic Diseases, Belgrade, Serbia
Address [1] 282245 0
Dr Subotica 13, Belgrade 11000, Serbia
Country [1] 282245 0
Serbia and Montenegro

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310728 0
Ethics committee, Clinical Center of Serbia
Ethics committee address [1] 310728 0
Pasterova 2, Belgrade 11000, Serbia
Ethics committee country [1] 310728 0
Serbia and Montenegro
Date submitted for ethics approval [1] 310728 0
Approval date [1] 310728 0
21/02/2019
Ethics approval number [1] 310728 0
31/28

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118662 0
Prof Brižita Ðordevic
Address 118662 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
Country 118662 0
Serbia and Montenegro
Phone 118662 0
+38163245062
Fax 118662 0
Email 118662 0
[email protected]
Contact person for public queries
Name 118663 0
Nevena Ivanovic
Address 118663 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
Country 118663 0
Serbia and Montenegro
Phone 118663 0
+381652358892
Fax 118663 0
Email 118663 0
[email protected]
Contact person for scientific queries
Name 118664 0
Nevena Ivanovic
Address 118664 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, Belgrade 11221, Serbia
Country 118664 0
Serbia and Montenegro
Phone 118664 0
+381652358892
Fax 118664 0
Email 118664 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Protection of private data.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 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.