Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on cognitive function and metabolic profiles in patients with Alzheimer's disease.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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60 patients with Alzheimer's disease of eligible at Golabchi (Kashan, Iran) and Sadeghyeh (Esfahan, Iran) Welfare Organizations in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients with Alzheimer's disease and aged 60 to 95 years will be included in this study. Patients with metabolic disorders, chronic infections and/or other clinically relevant disorders with exception of AD and consuming probiotic supplements within 6 weeks prior to the study, taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods will excluded.
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Intervention groups
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Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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Main outcome variables
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Cognitive function and metabolic profiles
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:
IRCT201511305623N60
Registration date:
2015-12-01, 1394/09/10
Registration timing:
retrospective
Last update:
2019-09-18, 1398/06/27
Update count:
1
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Registration date
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2015-12-01, 1394/09/10
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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 Sciences
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Expected recruitment start date
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2015-10-24, 1394/08/02
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Expected recruitment end date
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2015-11-01, 1394/08/10
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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 the effect of probiotic supplementation compared with the placebo on cognitive function and metabolic profiles in patients with Alzheimer's disease
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Public title
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Effect of supplementation in treatment of patients with Alzheimer's disease
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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 Alzheimer's disease
Aged 60 to 95 years
Exclusion criteria:
Patients with metabolic disorders
Patients with chronic infections and/or other clinically relevant disorders
Consuming probiotic supplements within 6 weeks prior to the study
Taking other forms of probiotics including probiotic yogurt, kefir, and other fermented foods
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Age
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From 60 years old to 95 years old
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Gender
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Both
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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
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 30) or placebo (n = 30). 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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Welfare Organizations, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2015-10-24, 1394/08/02
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Ethics committee reference number
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IR.Kaums.REC.1394.97
Health conditions studied
1
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Description of health condition studied
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Alzheimer's disease
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ICD-10 code
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F00
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ICD-10 code description
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Dementia in Alzheimer disease
Primary outcomes
1
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Description
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Cognitive function
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Mini Mental State Exam (MMSE)
Secondary 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 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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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 12 weeks of intervention
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Method of measurement
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Elisa kit
3
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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 12 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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Cholesterol
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Timepoint
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At the beginning of the study and after 12 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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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 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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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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Description
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LDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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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 12 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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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
11
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 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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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 12 weeks orally.
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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 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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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