Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus.
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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=25) or control (n=26).
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Settings and conduct
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Among patients with type 2 diabetes mellitus referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 51 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.
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Intervention groups
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Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (107 CFU), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene 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: Insulin (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:
IRCT201301195623N5
Registration date:
2013-02-23, 1391/12/05
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2013-02-23, 1391/12/05
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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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Kashan University of Medical Science and Sekkeh Gaz company
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Expected recruitment start date
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2013-02-12, 1391/11/24
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Expected recruitment end date
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2013-02-15, 1391/11/27
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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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The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with type 2 diabetes mellitus
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Public title
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The effects of a synbiotic food of fortified with beta-carotene in the treatment of 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 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
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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:
51
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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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2013-02-11, 1391/11/23
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Ethics committee reference number
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29/5/1/4138/پ
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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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
Secondary outcomes
1
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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
2
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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
3
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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
4
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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
5
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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
6
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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
7
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Description
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Malondialdehyde
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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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Nitric oxide
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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
9
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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 kit
10
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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
11
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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
12
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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
13
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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
14
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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
15
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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
16
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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
17
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Description
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VLDL
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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), 0.1 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene per 1 g, 9 g, thrice a day for 6 weeks.
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Category
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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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Kashan 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