Protocol summary
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Study aim
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Determine the effects of prebiotic supplementation on women with type 2 diabetes.
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Design
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This Randomized, double-blind study to determine the effects of prebiotic supplementation on women with type 2 diabetes will done. Patients were randomly divided to two groups based on block randomization procedure of size six by using random allocation software (RAS). Each block involves the patients with the same categorizes of BMI and age.
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Settings and conduct
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This randomized, double-blind clinical trial will performed on T2DM from the Iran Diabetes Society
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Participants/Inclusion and exclusion criteria
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Inclusion criteria were: having type 2 diabetes for more than six months, using anti-diabetic drugs and maintaining them in the period of the study and having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months. Type 2 diabetes was defined as a FPG level more than 126 mg/dl. Patients were excluded if they had history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases; if they were pregnant; smokers; lactating; consuming pre/probiotics’ products; antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin; and finally if they had a typical fiber intake more than 30g/d
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Intervention groups
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The intervention group: 10g/d resistant dextrin supplement
The control group: 10g/d maltodextrin for 8 weeks.
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Main outcome variables
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Cortisol, Perceived Stress, IL6, IL18, TNF, Leptin, Adiponectin, Insulin, FBS
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:
IRCT2016122720965N2
Registration date:
2017-04-02, 1396/01/13
Registration timing:
prospective
Last update:
2018-11-30, 1397/09/09
Update count:
2
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Registration date
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2017-04-02, 1396/01/13
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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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Vice chancellor for research, Tabriz University of Medical Sciences
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Expected recruitment start date
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2018-03-12, 1396/12/21
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Expected recruitment end date
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2018-05-22, 1397/03/01
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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 prebiotics effect on the level of perceived stress, cortisol, interferon gamma, and appetite in patients with type 2 diabetes.
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Public title
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Prebiotic effect in patients with type 2 diabetes.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having type 2 diabetes for more than six months according International Diabetes Federation (fasting blood sugar level more than 126 mg/dl)
Using anti-diabetic drugs and maintaining them in the period of the study
Having a normal diet and Body Mass Index (BMI) more than 25 kg/m2 in the last 3 months
Exclusion criteria:
Having history of gastrointestinal; cardiovascular; renal; thyroid; liver; or pancreatic diseases
Pregnancy and lactating
Smokers
Consuming prebiotic and probiotics’ products
Consuming antibiotics; antiacids; alcohol; anti-diarrheal; anti-inflammatory; lipid-lowering; laxatives or insulin
Having a typical fiber intake more than 30g/d.
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Age
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From 30 years old to 50 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
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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T2DM patients randomly allocated to two groups using a block randomization procedure, after matching of BMI and age.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Researcher and patients will not be aware of the type of intervention. The third person will distribute the supplement among patients.
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Placebo
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Used
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Assignment
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Parallel
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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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IR.TBZMED.REC.1395.949
Health conditions studied
1
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Description of health condition studied
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Type 2 Diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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Cortisol
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Kit
2
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Description
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Interfron gamma
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Kit
3
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Description
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Perceived stress
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Perceived stress questionnaire
4
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Description
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IL18
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
5
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Description
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Leptin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
6
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Description
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adiponectin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
7
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Description
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IL10
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Kit
8
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Description
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insulin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
9
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Description
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TNF
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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KIT
10
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Description
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IL6
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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KIT
11
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Description
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FBS
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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KIT
Secondary outcomes
1
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Description
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Appetite
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Questionnaire
2
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Description
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GHrelin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kite
3
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Description
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quality of life
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Questionnaire
4
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Description
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Tryptophan
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
5
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Description
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Kynurenine
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
6
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Description
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quality of sleep
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Questionnaire
7
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Description
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Alkaline phosphatase (ALP)
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
8
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Description
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Alanine aminotransferase (ALT)
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Kit
9
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Description
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Aspartate aminotransferase (AST)
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Kit
10
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Description
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total antioxidant capacity
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
11
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Description
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malondialdehyde
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
12
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Description
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soluble receptor for advanced glycation end-products
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
13
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Description
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total cholesterol
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
14
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Description
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triglyceride
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
15
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Description
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LDL
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
16
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Description
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HDL
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
17
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Description
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Catalase
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
18
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Description
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superoxide dismutase
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
19
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Description
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glutathione peroxidase
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
20
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Description
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carboxymethyl lysine
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
21
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Description
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Pentosidine
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
22
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Description
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obestatin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
23
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Description
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brain-derived neurotrophic factor
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
24
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Description
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Endotoxin
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
25
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Description
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Food intake
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Questionnaire
26
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Description
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Uric acid
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
27
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Description
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Blood urea nitrogen
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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kit
28
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Description
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Complete Blood Count
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Timepoint
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Before start intervention and 8 weeks after intervention
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Method of measurement
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Full Diff device
Intervention groups
1
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Description
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Intervention group 1 : prebiotic (Nutriose,10g/d, for 8 weeks)
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Category
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Treatment - Other
2
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Description
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Intervention group 2 (placebo): Matodextrin (matodextrin ,10g/d, for 8 weeks)
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Category
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Treatment - Other
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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Vice chancellor for reserach, Tabriz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data on the baseline characteristics of subjects will be provided in the article.
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When the data will become available and for how long
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2019
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To whom data/document is available
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Tabriz University of Medical Sciences
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Under which criteria data/document could be used
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The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
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From where data/document is obtainable
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Tabriz University of Medical Sciences
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What processes are involved for a request to access data/document
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The application must be submitted to Tabriz University of Medical Sciences. It will available, if Tabriz University of Medical Sciences is allowed.
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Comments
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