Effect of combined probiotic and selenium supplementation in treatment of patients with Alzheimer's disease

Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170612034497N5

Enrollment

Registered

2018-04-02

Start date

2017-12-29

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Alzheimer's disease. Alzheimer's disease

Interventions

Intervention 1: Intervention group: Probiotic oral capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Bifidobacterium lactis (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/

Eligibility

Sex/Gender

All

Age

55 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with Alzheimer's disease Individuals aged 55 to 100 years

Exclusion criteria

Exclusion criteria: Patients with metabolic syndrome Patients with diabetes Patients with cardiovascular disease Patients with chronic infections Consuming probiotic and/or synbiotic supplements within 8 weeks prior to the study Taking other forms of probiotics including probiotic yogurt and other fermented foods Taking antioxidants supplements

Design outcomes

Primary

Measure	Time frame
Cognitive function. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Mini Mental State Exam (MMSE).	—

Secondary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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