Stroke
Conditions
Keywords
Bifidobacterium longum OLP-01, Stroke, Cognitive function, Exercise performance, Nutritional status, Gut microbiota
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium longum OLP-01
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.
OTHERPlacebo
Subjects in placebo group will supplement with placebo powder per day for 12 weeks.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 20-75 years old * Diagnosed with stroke more than 3 months * Undergoing outpatient rehabilitation and the condition is stable
Exclusion criteria
* Aphasia, dementia or depression * BMI ≥ 35 kg/m2 * Cancer treatment in 3 months * Some severe disease may interfere patients to join the study * Failed to cooperate the examination and treatment because of emotion or mental condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go test (TUGT) | Week 0 | Exercise performance |
| Stroop color naming test | Week 0 | Cognitive function |
| Trail-making test A and B (TMT A and B) (change) | Change from week 0 to week 12 | Cognitive function |
| Stroop color naming test (change) | Change from week 0 to week 12 | Cognitive function |
| Montreal cognitive assessment (MoCA) | Week 0 | Cognitive function |
| Montreal cognitive assessment (MoCA) (change) | Change from week 0 to week 12 | Cognitive function |
| Trail-making test A and B (TMT A and B) | Week 0 | Cognitive function |
| Timed up and go test (TUGT) (change) | Change from week 0 to week 12 | Exercise performance |
| 6-min walking test | Week 0 | Exercise performance |
| 6-min walking test (change) | Change from week 0 to week 12 | Exercise performance |
| Albumin | Week 0 | Nutritional Status |
| Albumin (change) | Change from week 0 to week 12 | Nutritional Status |
| Pre-albumin | Week 0 | Nutritional Status |
| Pre-albumin (change) | Change from week 0 to week 12 | Nutritional Status |
| Transferrin | Week 0 | Nutritional Status |
| Transferrin (change) | Change from week 0 to week 12 | Nutritional Status |
| 3-day dietary record | Week 0 | Nutritional Status |
| 3-day dietary record (change) | Change from week 0 to week 12 | Nutritional Status |
| Mini-nutritional assessment (MNA) | Week 0 | Nutritional Status |
| Mini-nutritional assessment (MNA) (change) | Change from week 0 to week 12 | Nutritional Status |
| Relative abundance | Week 0 | Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus. |
| α-diversity | Week 0 | Gut microbiota |
| β-diversity | Week 0 | Gut microbiota |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Week 0 | Clinical data |
| Blood pressure (change) | Change from week 0 to week 12 | Clinical data |
| Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid) | Week 0 | Stroke related characteristics would collect form clinical data or ask form subjects directly |
| Medical history, drug use and life style questionnaires | Week 0 | 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. |
| Fasting blood glucose | Week 0 | Blood biochemistry |
| Fasting blood glucose (change) | Change from week 0 to week 12 | Blood biochemistry |
| Glycated hemoglobin A1c (HbA1c) | Week 0 | Blood biochemistry |
| Glycated hemoglobin A1c (HbA1c) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Total cholesterol (TC) | Week 0 | Blood biochemistry |
| Total cholesterol (TC) (change) | Change from week 0 to week 12 | Blood biochemistry |
| High density lipoprotein cholesterol (HDL-C) | Week 0 | Blood biochemistry |
| High density lipoprotein cholesterol (HDL-C) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Low density lipoprotein cholesterol (LDL-C) | Week 0 | Blood biochemistry |
| Low density lipoprotein cholesterol (LDL-C) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Triglycerides (TG) | Week 0 | Blood biochemistry |
| Triglycerides (TG) (change) | Change from week 0 to week 12 | Blood biochemistry |
| White blood cells (WBC) | Week 0 | Blood biochemistry |
| White blood cells (WBC) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Red blood cells (RBC) | Week 0 | Blood biochemistry |
| Red blood cells (RBC) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Hemoglobin (HB) | Week 0 | Blood biochemistry |
| Hemoglobin (HB) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Platelet count (PLT) | Week 0 | Blood biochemistry |
| Platelet count (PLT) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Hematocrit (HCT) | Week 0 | Blood biochemistry |
| Hematocrit (HCT) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Mean corpuscular volume (MCV) | Week 0 | Blood biochemistry |
| Mean corpuscular hemoglobin (MCH) | Week 0 | Blood biochemistry |
| Mean corpuscular hemoglobin (MCH) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Mean corpuscular hemoglobin concentration (MCHC) | Week 0 | Blood biochemistry |
| Mean corpuscular hemoglobin concentration (MCHC) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Neutrophils (NEUT) | Week 0 | Blood biochemistry (WBC counts) |
| Lymphocytes (LYM) | Week 0 | Blood biochemistry (WBC counts) |
| Monocytes (MONO) | Week 0 | Blood biochemistry (WBC counts) |
| Eosinophils (EOS) | Week 0 | Blood biochemistry (WBC counts) |
| Basophils (BASO) | Week 0 | Blood biochemistry (WBC counts) |
| Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) | Week 0 | Blood biochemistry (cytokines) |
| Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change) | Change from week 0 to week 12 | Blood biochemistry (cytokines) |
| C-reactive protein (CRP) | Week 0 | Blood biochemistry |
| C-reactive protein (CRP) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Mean corpuscular volume (MCV) (change) | Change from week 0 to week 12 | Blood biochemistry |
| Height | Week 0 | Anthropometry data |
| Height (change) | Change from week 0 to week 12 | Anthropometry data |
| Weight | Week 0 | Anthropometry data |
| Weight (change) | Change from week 0 to week 12 | Anthropometry data |
| Body mass index (BMI) | Week 0 | Anthropometry data Weight and height will be combined to report BMI in kg/m\^2 |
| Body mass index (BMI) (change) | Change from week 0 to week 12 | Anthropometry data Weight and height will be combined to report BMI in kg/m\^2 |
| Waist circumference | Week 0 | Anthropometry data |
| Waist circumference (change) | Change from week 0 to week 12 | Anthropometry data |
| Mid-upper arm circumference | Week 0 | Anthropometry data |
| Mid-upper arm circumference (change) | Change from week 0 to week 12 | Anthropometry data |
| Hip circumference | Week 0 | Anthropometry data |
| Hip circumference (change) | Change from week 0 to week 12 | Anthropometry data |
| Calf circumference | Week 0 | Anthropometry data |
| Calf circumference (change) | Change from week 0 to week 12 | Anthropometry data |
| Waist to hip ratio | Week 0 | Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio |
| Waist to hip ratio (change) | Change from week 0 to week 12 | Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio |
| Muscle mass | Week 0 | Body composition |
| Muscle mass (change) | Change from week 0 to week 12 | Body composition |
| Body fat | Week 0 | Body composition |
| Body fat (change) | Change from week 0 to week 12 | Body composition |
| Basal metabolic rate | Week 0 | Body composition |
| Basal metabolic rate (change) | Change from week 0 to week 12 | Body composition |
Countries
Taiwan
Outcome results
None listed