Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with gestational diabetes.
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Design
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Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive synbiotic supplements (n=35) or placebo (n=35).
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Settings and conduct
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Among patients with gestational diabetes referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with gestational diabetes, aged 18 to 40 years.
Exclusion criteria: Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods, taking insulin, placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, smokers, kidney or liver diseases.
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Intervention groups
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Intervention group: Synbiotic capsule daily (Tak Gen Zist, Tehran, Iran) for 6 weeks orally. Control group: Placebo capsule (Tak Gen Zist, Tehran, Iran), for 6 weeks orally.
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Main outcome variables
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Outcomes: Insulin Metabolism (primary outcomes) and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201605085623N77
Registration date:
2016-05-11, 1395/02/22
Registration timing:
retrospective
Last update:
2019-09-19, 1398/06/28
Update count:
1
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Registration date
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2016-05-11, 1395/02/22
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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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Arak University of Medical Sciences
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Expected recruitment start date
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2016-02-20, 1394/12/01
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Expected recruitment end date
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2016-03-19, 1394/12/29
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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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Clinical trial of the effect of Synbiotic supplementation compared with the placebo on metabolic profiles in patients with gestational diabetes
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Public title
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Effect of supplementation in treatment of patients with gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with gestational diabetes
Aged 18 to 40 years
Exclusion criteria:
Taking synbiotic or probiotic including probiotic yogurt, kefir and other fermented foods
Taking insulin
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Smokers
Kidney or liver diseases
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed.
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Placebo
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Used
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Assignment
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Single
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Other design features
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Random assignment will be done by the use of computer-generated random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2016-02-19, 1394/11/30
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Ethics committee reference number
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IR.ARAKMU.REC.1395.22
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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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 and after 6 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Cholesterol
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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LDL-cholesterol
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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VLDL-cholesterol
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Timepoint
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At the beginning of the study and after 6 weeks of intervention
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Method of measurement
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Enzymatic kit
Intervention groups
1
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Description
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Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), 800 mg inulin, daily, for 6 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 6 weeks orally.
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Category
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Treatment - Drugs
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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Arak 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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable