Effect of probiotic supplementation in patients with type 2 diabetes

Effect of probiotic supplementation on cognitive function and BDNF in patients with type 2 diabetes

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090901002394N44

Enrollment

Registered

2019-11-25

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus. diabetes (mellitus)(nonobese)(obese): adult-onsetmaturity-onset nonketotic stable non-insulin-dependent diabetes of the young

Interventions

Intervention 1: Intervention group: 2 capsules of 500mg familact daily for 12 weeks. Intervention 2: Control group: Take 2 placebo capsules daily for 12 weeks.

Eligibility

Sex/Gender

All

Age

45 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsimakheradmand

Iran University of Medical Sciences

sima.kherad@yahoo.com+98 21 8670 4805

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026