Stroke is a syndrome of acute, focal neurological deficit attributed to vascular injury of the central nervous system. It was the 2nd leading cause of death worldwide and accompanied by high disability rate also increases the social burden.Our research is to investigate the effects of intervention with Bifidobacterium longum OLP-01 on cognitive function, exercise performance, nutritional status and gut microbiota in stroke patients. 1. Study population: We will recruit 120 stroke patients and the inclusion criteria are: (1) Aged 20-75 years old, (2) Diagnosed with stroke more than 3 months, (3) Undergoing outpatient rehabilitation and the condition is stable. The exclusion criteria are: (1) Aphasia, dementia or depression, (2) BMI ≥ 35 kg/m2, (3) Cancer treatment in 3 months, (4) Some severe disease may interfere patients to join the study, (5) Failed to cooperate the examination and treatment because of emotion or mental condition. 2. Study design: A two-arm single-blind randomized controlled clinical trial will be performed for 12 weeks and the subjects will be divided in to 2 groups: (1) placebo group, (2) supplement group. Subjects were asked to supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day or placebo for 12 weeks. Medical history, drug use and life style questionnaires were giving before intervention. Outcomes will be assess in week 0 and week 12 during intervention. 3\. Outcome assessment: 1. Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio. 2. Body composition: muscle mass, body fat, basal metabolic rate. 3. Clinical data: blood pressure, stroke related characteristics. 4. Blood biochemistry: A. Nutritional status: albumin, prealbumin, transferrin. B. Glycemic profiles: fasting blood glucose, glycated hemoglobin A1c (HbA1c). C. Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG). D. Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC). E. WBC differential counts: neutrophils (NEUT), lymphocytes (LYM), monocytes (MONO), eosinophils (EOS), basophils (BASO). F. C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-α). 5. Gut microbiota: relative abundance, α-diversity, β-diversity. 6. Nutritional status: 3-day dietary record, mini-nutritional assessment (MNA). 7. Cognitive function: Montreal cognitive assessment (MoCA), trail-making test A and B (TMT A and B), Stroop color naming test. 8. Exercise performance: timed up and go test (TUGT), 6-min walking test. The purpose of the study is to investigate the intervention of Bifidobacterium longum OLP-01 supplement on cognitive function, physiological performance, nutritional status, and gut microbiota in stroke patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Bifidobacterium longum OLP-01 is one of probiotics. Subjects in OLP-01 group will supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day for 12 weeks.
Subjects in placebo group will supplement with placebo powder per day for 12 weeks.
Department of rehabilitation, ShuangHo Hospital
New Taipei City, Taiwan
Department of rehabilitation, Taipei Medical University Hospital
Taipei, Taiwan
Department of rehabilitation, WanFang Hospital
Taipei, Taiwan
Montreal cognitive assessment (MoCA)
Cognitive function
Time frame: Week 0
Montreal cognitive assessment (MoCA)
Cognitive function
Time frame: Week 12
Montreal cognitive assessment (MoCA) (change)
Cognitive function
Time frame: Change from week 0 to week 12
Trail-making test A and B (TMT A and B)
Cognitive function
Time frame: Week 0
Trail-making test A and B (TMT A and B)
Cognitive function
Time frame: Week 12
Trail-making test A and B (TMT A and B) (change)
Cognitive function
Time frame: Change from week 0 to week 12
Stroop color naming test
Cognitive function
Time frame: Week 0
Stroop color naming test
Cognitive function
Time frame: Week 12
Stroop color naming test (change)
Cognitive function
Time frame: Change from week 0 to week 12
Timed up and go test (TUGT)
Exercise performance
Time frame: Week 0
Timed up and go test (TUGT)
Exercise performance
Time frame: Week 12
Timed up and go test (TUGT) (change)
Exercise performance
Time frame: Change from week 0 to week 12
6-min walking test
Exercise performance
Time frame: Week 0
6-min walking test
Exercise performance
Time frame: Week 12
6-min walking test (change)
Exercise performance
Time frame: Change from week 0 to week 12
Albumin
Nutritional Status
Time frame: Week 0
Albumin
Nutritional Status
Time frame: Week 12
Albumin (change)
Nutritional Status
Time frame: Change from week 0 to week 12
Pre-albumin
Nutritional Status
Time frame: Week 0
Pre-albumin
Nutritional Status
Time frame: Week 12
Pre-albumin (change)
Nutritional Status
Time frame: Change from week 0 to week 12
Transferrin
Nutritional Status
Time frame: Week 0
Transferrin
Nutritional Status
Time frame: Week 12
Transferrin (change)
Nutritional Status
Time frame: Change from week 0 to week 12
3-day dietary record
Nutritional Status
Time frame: Week 0
3-day dietary record
Nutritional Status
Time frame: Week 12
3-day dietary record (change)
Nutritional Status
Time frame: Change from week 0 to week 12
Mini-nutritional assessment (MNA)
Nutritional Status
Time frame: Week 0
Mini-nutritional assessment (MNA)
Nutritional Status
Time frame: Week 12
Mini-nutritional assessment (MNA) (change)
Nutritional Status
Time frame: Change from week 0 to week 12
Relative abundance
Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.
Time frame: Week 0
Relative abundance
Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.
Time frame: Week 12
α-diversity
Gut microbiota
Time frame: Week 0
α-diversity
Gut microbiota
Time frame: Week 12
β-diversity
Gut microbiota
Time frame: Week 0
β-diversity
Gut microbiota
Time frame: Week 12
Height
Anthropometry data
Time frame: Week 0
Height
Anthropometry data
Time frame: Week 12
Height (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Weight
Anthropometry data
Time frame: Week 0
Weight
Anthropometry data
Time frame: Week 12
Weight (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Body mass index (BMI)
Anthropometry data Weight and height will be combined to report BMI in kg/m\^2
Time frame: Week 0
Body mass index (BMI)
Anthropometry data Weight and height will be combined to report BMI in kg/m\^2
Time frame: Week 12
Body mass index (BMI) (change)
Anthropometry data Weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from week 0 to week 12
Waist circumference
Anthropometry data
Time frame: Week 0
Waist circumference
Anthropometry data
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 12
Waist circumference (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Mid-upper arm circumference
Anthropometry data
Time frame: Week 0
Mid-upper arm circumference
Anthropometry data
Time frame: Week 12
Mid-upper arm circumference (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Hip circumference
Anthropometry data
Time frame: Week 0
Hip circumference
Anthropometry data
Time frame: Week 12
Hip circumference (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Calf circumference
Anthropometry data
Time frame: Week 0
Calf circumference
Anthropometry data
Time frame: Week 12
Calf circumference (change)
Anthropometry data
Time frame: Change from week 0 to week 12
Waist to hip ratio
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Time frame: Week 0
Waist to hip ratio
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Time frame: Week 12
Waist to hip ratio (change)
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Time frame: Change from week 0 to week 12
Muscle mass
Body composition
Time frame: Week 0
Muscle mass
Body composition
Time frame: Week 12
Muscle mass (change)
Body composition
Time frame: Change from week 0 to week 12
Body fat
Body composition
Time frame: Week 0
Body fat
Body composition
Time frame: Week 12
Body fat (change)
Body composition
Time frame: Change from week 0 to week 12
Basal metabolic rate
Body composition
Time frame: Week 0
Basal metabolic rate
Body composition
Time frame: Week 12
Basal metabolic rate (change)
Body composition
Time frame: Change from week 0 to week 12
Blood pressure
Clinical data
Time frame: Week 0
Blood pressure
Clinical data
Time frame: Week 12
Blood pressure (change)
Clinical data
Time frame: Change from week 0 to week 12
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Stroke related characteristics would collect form clinical data or ask form subjects directly
Time frame: Week 0
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Stroke related characteristics would collect form clinical data or ask form subjects directly
Time frame: Week 12
Medical history, drug use and life style questionnaires
Clinical data This questionnaires including 3 parts (medical history, drug use and life style). Medical history and drug use will write by subjects. Life style (e.g. smocking habit, exercise frequency) will ask the subjects.
Time frame: Week 0
Medical history, drug use and life style questionnaires
Clinical data This questionnaires including 3 parts (medical history, drug use and life style). Medical history and drug use will write by subjects. Life style (e.g. smocking habit, exercise frequency) will ask the subjects.
Time frame: Week 12
Fasting blood glucose
Blood biochemistry
Time frame: Week 0
Fasting blood glucose
Blood biochemistry
Time frame: Week 12
Fasting blood glucose (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Glycated hemoglobin A1c (HbA1c)
Blood biochemistry
Time frame: Week 0
Glycated hemoglobin A1c (HbA1c)
Blood biochemistry
Time frame: Week 12
Glycated hemoglobin A1c (HbA1c) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Total cholesterol (TC)
Blood biochemistry
Time frame: Week 0
Total cholesterol (TC)
Blood biochemistry
Time frame: Week 12
Total cholesterol (TC) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
High density lipoprotein cholesterol (HDL-C)
Blood biochemistry
Time frame: Week 0
High density lipoprotein cholesterol (HDL-C)
Blood biochemistry
Time frame: Week 12
High density lipoprotein cholesterol (HDL-C) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Low density lipoprotein cholesterol (LDL-C)
Blood biochemistry
Time frame: Week 0
Low density lipoprotein cholesterol (LDL-C)
Blood biochemistry
Time frame: Week 12
Low density lipoprotein cholesterol (LDL-C) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Triglycerides (TG)
Blood biochemistry
Time frame: Week 0
Triglycerides (TG)
Blood biochemistry
Time frame: Week 12
Triglycerides (TG) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
White blood cells (WBC)
Blood biochemistry
Time frame: Week 0
White blood cells (WBC)
Blood biochemistry
Time frame: Week 12
White blood cells (WBC) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Red blood cells (RBC)
Blood biochemistry
Time frame: Week 0
Red blood cells (RBC)
Blood biochemistry
Time frame: Week 12
Red blood cells (RBC) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Hemoglobin (HB)
Blood biochemistry
Time frame: Week 0
Hemoglobin (HB)
Blood biochemistry
Time frame: Week 12
Hemoglobin (HB) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Platelet count (PLT)
Blood biochemistry
Time frame: Week 0
Platelet count (PLT)
Blood biochemistry
Time frame: Week 12
Platelet count (PLT) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Hematocrit (HCT)
Blood biochemistry
Time frame: Week 0
Hematocrit (HCT)
Blood biochemistry
Time frame: Week 12
Hematocrit (HCT) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Mean corpuscular volume (MCV)
Blood biochemistry
Time frame: Week 0
Mean corpuscular volume (MCV)
Blood biochemistry
Time frame: Week 12
Mean corpuscular volume (MCV) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Mean corpuscular hemoglobin (MCH)
Blood biochemistry
Time frame: Week 0
Mean corpuscular hemoglobin (MCH)
Blood biochemistry
Time frame: Week 12
Mean corpuscular hemoglobin (MCH) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Mean corpuscular hemoglobin concentration (MCHC)
Blood biochemistry
Time frame: Week 0
Mean corpuscular hemoglobin concentration (MCHC)
Blood biochemistry
Time frame: Week 12
Mean corpuscular hemoglobin concentration (MCHC) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Time frame: Week 0
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Time frame: Week 12
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Time frame: Change from week 0 to week 12
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Time frame: Week 0
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Time frame: Week 12
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Time frame: Change from week 0 to week 12
Monocytes (MONO)
Blood biochemistry (WBC counts)
Time frame: Week 0
Monocytes (MONO)
Blood biochemistry (WBC counts)
Time frame: Week 12
Monocytes (MONO)
Blood biochemistry (WBC counts)
Time frame: Change from week 0 to week 12
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Time frame: Week 0
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Time frame: Week 12
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Time frame: Change from week 0 to week 12
Basophils (BASO)
Blood biochemistry (WBC counts)
Time frame: Week 0
Basophils (BASO)
Blood biochemistry (WBC counts)
Time frame: Week 12
Basophils (BASO)
Blood biochemistry (WBC counts)
Time frame: Change from week 0 to week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
Blood biochemistry (cytokines)
Time frame: Week 0
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
Blood biochemistry (cytokines)
Time frame: Week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change)
Blood biochemistry (cytokines)
Time frame: Change from week 0 to week 12
C-reactive protein (CRP)
Blood biochemistry
Time frame: Week 0
C-reactive protein (CRP)
Blood biochemistry
Time frame: Week 12
C-reactive protein (CRP) (change)
Blood biochemistry
Time frame: Change from week 0 to week 12