Protocol summary
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Study aim
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Objective: The effect of probiotic Gaz enriched with inulin on the biochemical parameters including fasting plasma glucose, lipid profiles, inflammatory factors and stress oxidative in patients with type 2 diabetes.
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Design
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Study design: Randomized cross-over double-blind controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive synbiotic (n=35) or control (n=35).
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Settings and conduct
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Among patients with type 2 diabetes mellitus referred to Gholabchi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 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. Synbiotic and control are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients with type 2 diabetes mellitus aged 35 to 70 years. Exclusion Criteria: Pregnant, using insulin or vitamin supplements, liver and inflammatory diseases, coronary heart disease, allergies, short bowel syndrome.
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Intervention groups
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Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
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Main outcome variables
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Outcomes: Inflammatory factor and calcium (primary outcome), and lipid profiles, biomarkers of inflammation and oxidative stress (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:
IRCT201201195623N1
Registration date:
2012-02-12, 1390/11/23
Registration timing:
retrospective
Last update:
2019-09-24, 1398/07/02
Update count:
1
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Registration date
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2012-02-12, 1390/11/23
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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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Qom University Of Medical Science and Sekkeh Gaz (Isfahan)
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Expected recruitment start date
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2010-08-21, 1389/05/30
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Expected recruitment end date
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2010-09-21, 1389/06/30
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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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Effects of synbiotic Gaz on fasting plasma glucose and lipid profiles of diabetic subjects
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Public title
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Effects of probiotic Gaz enriched with Inolin in diabetes treat
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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 type 2 diabetes mellitus aged 35 to 70 years
Exclusion criteria:
Pregnant
Using insulin or vitamin supplements
Liver and inflammatory diseases
Coronary heart disease
Allergies
Short bowel syndrome
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Age
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From 35 years old to 70 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
- 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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Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Not used
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Assignment
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Crossover
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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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2010-08-20, 1389/05/29
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Ethics committee reference number
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91288
Health conditions studied
1
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Description of health condition studied
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diabetes- cardiovascular
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ICD-10 code
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E11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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Hs-CRP
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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
2
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Description
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Calcium
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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
Secondary 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
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
3
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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
4
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Description
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Total 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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HDL
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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
6
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Description
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Total antioxidant
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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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Spectrophotometry
7
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Description
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Glutathione
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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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Spectrophotometry
8
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Description
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Liver enzymes
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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
9
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Description
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Magnesium
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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
10
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Description
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Iron
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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
11
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Description
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Systolic blood pressure
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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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Manometer
12
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Description
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Diastolic blood pressure
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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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Manometer
13
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Description
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LDL
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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
14
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Description
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Uric acid
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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
15
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Description
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Bilirubin
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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 viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.04 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
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Category
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Treatment - Other
2
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Description
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Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 9 g, thrice a day for 6 weeks.
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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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Qom University Of Medical Science
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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