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Effect of probiotic supplementation in patients with type 2 diabetes

Phase 3
Recruiting
Conditions
Type 2 diabetes mellitus.
diabetes (mellitus)(nonobese)(obese): adult-onsetmaturity-onset nonketotic stable non-insulin-dependent diabetes of the young
Registration Number
IRCT20090901002394N44
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
84
Inclusion Criteria

Willing to participate and signing informed consent
Having type 2 diabetes based on medical records
At least 2 years history of type 2 diabetes
No change in the type and dose of medication taken 8 weeks before the intervention
Age 45-65
Not eating probiotic-containing foods for the past 4 weeks

Exclusion Criteria

Cancer, severe liver and kidney disorders, heart failure and surgery and other endocrine disorders
Pregnancy and lactation and hormone-sensitive conditions
Use of liver, anticoagulant, and platelet-degrading drugs
Use of antidepressants and other drugs that affect the nerves
Insulin injection
Contraceptive use
Recent dietary supplements (no case if calcium - vitamin D and group B supplements are routinely consumed for the past 6 months)
Use of antibiotics for the past 1 month
Tobacco, drugs and alcohol
weight loss diet and weight changes over 5% in the last 3 months

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cognitive function. Timepoint: at baseline, and after 2 month. Method of measurement: Addenbrooke’s Cognitive Examination - Trail Making Test.;BDNF. Timepoint: at baseline, and after 2 month. Method of measurement: Eliza.
Secondary Outcome Measures
NameTimeMethod
Physical activity. Timepoint: beginning and end of intervention. Method of measurement: IPAQ questionnaire.;Energy intake. Timepoint: beginning and end of intervention. Method of measurement: Three-day food record.
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