Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Pre-albumin
研究概览
简要总结
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.
- 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.
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Outcome assessment:
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Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio.
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Body composition: muscle mass, body fat, basal metabolic rate.
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Clinical data: blood pressure, stroke related characteristics.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-75 years old
- •Diagnosed with stroke more than 3 months
- •Undergoing outpatient rehabilitation and the condition is stable
排除标准
- •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.
研究组 & 干预措施
Placebo group
Subjects in placebo group will treat with placebo.
干预措施: Placebo (Other)
Supplement group
Subjects in supplement group will treat with Bifidobacterium longum OLP-01.
干预措施: Bifidobacterium longum OLP-01 (Dietary Supplement)
结局指标
主要结局
Pre-albumin
时间窗: Week 12
Nutritional Status
Stroop color naming test
时间窗: Week 12
Cognitive function
3-day dietary record (change)
时间窗: Change from week 0 to week 12
Nutritional Status
Stroop color naming test (change)
时间窗: Change from week 0 to week 12
Cognitive function
Montreal cognitive assessment (MoCA)
时间窗: Week 12
Cognitive function
Montreal cognitive assessment (MoCA) (change)
时间窗: Change from week 0 to week 12
Cognitive function
Transferrin
时间窗: Week 12
Nutritional Status
Relative abundance
时间窗: Week 12
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
时间窗: Week 12
Gut microbiota
Trail-making test A and B (TMT A and B) (change)
时间窗: Change from week 0 to week 12
Cognitive function
Pre-albumin (change)
时间窗: Change from week 0 to week 12
Nutritional Status
Transferrin (change)
时间窗: Change from week 0 to week 12
Nutritional Status
Mini-nutritional assessment (MNA) (change)
时间窗: Change from week 0 to week 12
Nutritional Status
β-diversity
时间窗: Week 12
Gut microbiota
Timed up and go test (TUGT) (change)
时间窗: Change from week 0 to week 12
Exercise performance
6-min walking test (change)
时间窗: Change from week 0 to week 12
Exercise performance
Trail-making test A and B (TMT A and B)
时间窗: Week 12
Cognitive function
Timed up and go test (TUGT)
时间窗: Week 12
Exercise performance
6-min walking test
时间窗: Week 12
Exercise performance
Albumin
时间窗: Week 12
Nutritional Status
3-day dietary record
时间窗: Week 12
Nutritional Status
Albumin (change)
时间窗: Change from week 0 to week 12
Nutritional Status
Mini-nutritional assessment (MNA)
时间窗: Week 12
Nutritional Status
6-min walking test
时间窗: Week 0
Exercise performance
Albumin
时间窗: Week 0
Nutritional Status
Montreal cognitive assessment (MoCA)
时间窗: Week 0
Cognitive function
Trail-making test A and B (TMT A and B)
时间窗: Week 0
Cognitive function
Stroop color naming test
时间窗: Week 0
Cognitive function
Timed up and go test (TUGT)
时间窗: Week 0
Exercise performance
3-day dietary record
时间窗: Week 0
Nutritional Status
Pre-albumin
时间窗: Week 0
Nutritional Status
Transferrin
时间窗: Week 0
Nutritional Status
Mini-nutritional assessment (MNA)
时间窗: Week 0
Nutritional Status
Relative abundance
时间窗: 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
时间窗: Week 0
Gut microbiota
β-diversity
时间窗: Week 0
Gut microbiota
次要结局
- Mean corpuscular volume (MCV) (change)(Change from week 0 to week 12)
- Height (change)(Change from week 0 to week 12)
- Height(Week 12)
- Weight(Week 12)
- Body mass index (BMI)(Week 12)
- Calf circumference(Week 12)
- Calf circumference (change)(Change from week 0 to week 12)
- Body mass index (BMI) (change)(Change from week 0 to week 12)
- Weight (change)(Change from week 0 to week 12)
- Waist circumference (change)(Change from week 0 to week 12)
- Mid-upper arm circumference(Week 12)
- Basal metabolic rate(Week 12)
- Basal metabolic rate (change)(Change from week 0 to week 12)
- Mid-upper arm circumference (change)(Change from week 0 to week 12)
- Hip circumference (change)(Change from week 0 to week 12)
- Body fat (change)(Change from week 0 to week 12)
- Blood pressure (change)(Change from week 0 to week 12)
- Red blood cells (RBC)(Week 12)
- Hemoglobin (HB)(Week 12)
- Waist circumference(Week 12)
- Hip circumference(Week 12)
- Waist to hip ratio(Week 12)
- Muscle mass(Week 12)
- Muscle mass (change)(Change from week 0 to week 12)
- Blood pressure(Week 12)
- Fasting blood glucose(Week 12)
- Fasting blood glucose (change)(Change from week 0 to week 12)
- High density lipoprotein cholesterol (HDL-C)(Week 12)
- High density lipoprotein cholesterol (HDL-C) (change)(Change from week 0 to week 12)
- Low density lipoprotein cholesterol (LDL-C) (change)(Change from week 0 to week 12)
- Red blood cells (RBC) (change)(Change from week 0 to week 12)
- Hematocrit (HCT)(Week 12)
- Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)(Week 12)
- Medical history, drug use and life style questionnaires(Week 12)
- Total cholesterol (TC)(Week 12)
- Total cholesterol (TC) (change)(Change from week 0 to week 12)
- Low density lipoprotein cholesterol (LDL-C)(Week 12)
- Triglycerides (TG) (change)(Change from week 0 to week 12)
- White blood cells (WBC)(Week 12)
- Platelet count (PLT) (change)(Change from week 0 to week 12)
- Waist to hip ratio (change)(Change from week 0 to week 12)
- Body fat(Week 12)
- Glycated hemoglobin A1c (HbA1c) (change)(Change from week 0 to week 12)
- Triglycerides (TG)(Week 12)
- White blood cells (WBC) (change)(Change from week 0 to week 12)
- Glycated hemoglobin A1c (HbA1c)(Week 12)
- Platelet count (PLT)(Week 12)
- Hematocrit (HCT) (change)(Change from week 0 to week 12)
- Mean corpuscular hemoglobin (MCH)(Week 12)
- Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change)(Change from week 0 to week 12)
- C-reactive protein (CRP) (change)(Change from week 0 to week 12)
- Mean corpuscular volume (MCV)(Week 12)
- Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)(Week 12)
- C-reactive protein (CRP)(Week 12)
- Hemoglobin (HB) (change)(Change from week 0 to week 12)
- Mean corpuscular hemoglobin (MCH) (change)(Change from week 0 to week 12)
- Mean corpuscular hemoglobin concentration (MCHC)(Week 12)
- Mean corpuscular hemoglobin concentration (MCHC) (change)(Change from week 0 to week 12)
- Neutrophils (NEUT)(Change from week 0 to week 12)
- Eosinophils (EOS)(Change from week 0 to week 12)
- Lymphocytes (LYM)(Change from week 0 to week 12)
- Monocytes (MONO)(Change from week 0 to week 12)
- Basophils (BASO)(Change from week 0 to week 12)
- Height(Week 0)
- Weight(Week 0)
- Body mass index (BMI)(Week 0)
- Waist circumference(Week 0)
- Mid-upper arm circumference(Week 0)
- Hip circumference(Week 0)
- Calf circumference(Week 0)
- Waist to hip ratio(Week 0)
- Muscle mass(Week 0)
- Body fat(Week 0)
- Basal metabolic rate(Week 0)
- Blood pressure(Week 0)
- Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)(Week 0)
- Medical history, drug use and life style questionnaires(Week 0)
- Fasting blood glucose(Week 0)
- Glycated hemoglobin A1c (HbA1c)(Week 0)
- Total cholesterol (TC)(Week 0)
- High density lipoprotein cholesterol (HDL-C)(Week 0)
- Low density lipoprotein cholesterol (LDL-C)(Week 0)
- Triglycerides (TG)(Week 0)
- White blood cells (WBC)(Week 0)
- Red blood cells (RBC)(Week 0)
- Hemoglobin (HB)(Week 0)
- Platelet count (PLT)(Week 0)
- Hematocrit (HCT)(Week 0)
- Mean corpuscular volume (MCV)(Week 0)
- Mean corpuscular hemoglobin (MCH)(Week 0)
- Mean corpuscular hemoglobin concentration (MCHC)(Week 0)
- Neutrophils (NEUT)(Week 0)
- Neutrophils (NEUT)(Week 12)
- Lymphocytes (LYM)(Week 0)
- Lymphocytes (LYM)(Week 12)
- Monocytes (MONO)(Week 0)
- Monocytes (MONO)(Week 12)
- Eosinophils (EOS)(Week 0)
- Eosinophils (EOS)(Week 12)
- Basophils (BASO)(Week 0)
- Basophils (BASO)(Week 12)
- Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)(Week 0)
- C-reactive protein (CRP)(Week 0)