Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients

Stroke Clinical Trial

Official title:

Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05477732
• Other study ID #: N202011038
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: February 11, 2023

Study information

• Verified date: July 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 11, 2023
• Est. primary completion date: February 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Dietary Supplement:
• Bifidobacterium 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.

Other:
• Placebo
Subjects in placebo group will supplement with placebo powder per day for 12 weeks.

Locations

Country	Name	City	State
Taiwan	Department of rehabilitation, ShuangHo Hospital	New Taipei City
Taiwan	Department of rehabilitation, Taipei Medical University Hospital	Taipei city
Taiwan	Department of rehabilitation, WanFang Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal cognitive assessment (MoCA)	Cognitive function	Week 0
Primary	Montreal cognitive assessment (MoCA)	Cognitive function	Week 12
Primary	Montreal cognitive assessment (MoCA) (change)	Cognitive function	Change from week 0 to week 12
Primary	Trail-making test A and B (TMT A and B)	Cognitive function	Week 0
Primary	Trail-making test A and B (TMT A and B)	Cognitive function	Week 12
Primary	Trail-making test A and B (TMT A and B) (change)	Cognitive function	Change from week 0 to week 12
Primary	Stroop color naming test	Cognitive function	Week 0
Primary	Stroop color naming test	Cognitive function	Week 12
Primary	Stroop color naming test (change)	Cognitive function	Change from week 0 to week 12
Primary	Timed up and go test (TUGT)	Exercise performance	Week 0
Primary	Timed up and go test (TUGT)	Exercise performance	Week 12
Primary	Timed up and go test (TUGT) (change)	Exercise performance	Change from week 0 to week 12
Primary	6-min walking test	Exercise performance	Week 0
Primary	6-min walking test	Exercise performance	Week 12
Primary	6-min walking test (change)	Exercise performance	Change from week 0 to week 12
Primary	Albumin	Nutritional Status	Week 0
Primary	Albumin	Nutritional Status	Week 12
Primary	Albumin (change)	Nutritional Status	Change from week 0 to week 12
Primary	Pre-albumin	Nutritional Status	Week 0
Primary	Pre-albumin	Nutritional Status	Week 12
Primary	Pre-albumin (change)	Nutritional Status	Change from week 0 to week 12
Primary	Transferrin	Nutritional Status	Week 0
Primary	Transferrin	Nutritional Status	Week 12
Primary	Transferrin (change)	Nutritional Status	Change from week 0 to week 12
Primary	3-day dietary record	Nutritional Status	Week 0
Primary	3-day dietary record	Nutritional Status	Week 12
Primary	3-day dietary record (change)	Nutritional Status	Change from week 0 to week 12
Primary	Mini-nutritional assessment (MNA)	Nutritional Status	Week 0
Primary	Mini-nutritional assessment (MNA)	Nutritional Status	Week 12
Primary	Mini-nutritional assessment (MNA) (change)	Nutritional Status	Change from week 0 to week 12
Primary	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.	Week 0
Primary	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.	Week 12
Primary	a-diversity	Gut microbiota	Week 0
Primary	a-diversity	Gut microbiota	Week 12
Primary	ß-diversity	Gut microbiota	Week 0
Primary	ß-diversity	Gut microbiota	Week 12
Secondary	Height	Anthropometry data	Week 0
Secondary	Height	Anthropometry data	Week 12
Secondary	Height (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Weight	Anthropometry data	Week 0
Secondary	Weight	Anthropometry data	Week 12
Secondary	Weight (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Body mass index (BMI)	Anthropometry data Weight and height will be combined to report BMI in kg/m^2	Week 0
Secondary	Body mass index (BMI)	Anthropometry data Weight and height will be combined to report BMI in kg/m^2	Week 12
Secondary	Body mass index (BMI) (change)	Anthropometry data Weight and height will be combined to report BMI in kg/m^2	Change from week 0 to week 12
Secondary	Waist circumference	Anthropometry data	Week 0
Secondary	Waist circumference	Anthropometry data	Week 12
Secondary	Waist circumference (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Mid-upper arm circumference	Anthropometry data	Week 0
Secondary	Mid-upper arm circumference	Anthropometry data	Week 12
Secondary	Mid-upper arm circumference (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Hip circumference	Anthropometry data	Week 0
Secondary	Hip circumference	Anthropometry data	Week 12
Secondary	Hip circumference (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Calf circumference	Anthropometry data	Week 0
Secondary	Calf circumference	Anthropometry data	Week 12
Secondary	Calf circumference (change)	Anthropometry data	Change from week 0 to week 12
Secondary	Waist to hip ratio	Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio	Week 0
Secondary	Waist to hip ratio	Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio	Week 12
Secondary	Waist to hip ratio (change)	Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio	Change from week 0 to week 12
Secondary	Muscle mass	Body composition	Week 0
Secondary	Muscle mass	Body composition	Week 12
Secondary	Muscle mass (change)	Body composition	Change from week 0 to week 12
Secondary	Body fat	Body composition	Week 0
Secondary	Body fat	Body composition	Week 12
Secondary	Body fat (change)	Body composition	Change from week 0 to week 12
Secondary	Basal metabolic rate	Body composition	Week 0
Secondary	Basal metabolic rate	Body composition	Week 12
Secondary	Basal metabolic rate (change)	Body composition	Change from week 0 to week 12
Secondary	Blood pressure	Clinical data	Week 0
Secondary	Blood pressure	Clinical data	Week 12
Secondary	Blood pressure (change)	Clinical data	Change from week 0 to week 12
Secondary	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	Week 0
Secondary	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	Week 12
Secondary	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.	Week 0
Secondary	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.	Week 12
Secondary	Fasting blood glucose	Blood biochemistry	Week 0
Secondary	Fasting blood glucose	Blood biochemistry	Week 12
Secondary	Fasting blood glucose (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Glycated hemoglobin A1c (HbA1c)	Blood biochemistry	Week 0
Secondary	Glycated hemoglobin A1c (HbA1c)	Blood biochemistry	Week 12
Secondary	Glycated hemoglobin A1c (HbA1c) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Total cholesterol (TC)	Blood biochemistry	Week 0
Secondary	Total cholesterol (TC)	Blood biochemistry	Week 12
Secondary	Total cholesterol (TC) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	High density lipoprotein cholesterol (HDL-C)	Blood biochemistry	Week 0
Secondary	High density lipoprotein cholesterol (HDL-C)	Blood biochemistry	Week 12
Secondary	High density lipoprotein cholesterol (HDL-C) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Low density lipoprotein cholesterol (LDL-C)	Blood biochemistry	Week 0
Secondary	Low density lipoprotein cholesterol (LDL-C)	Blood biochemistry	Week 12
Secondary	Low density lipoprotein cholesterol (LDL-C) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Triglycerides (TG)	Blood biochemistry	Week 0
Secondary	Triglycerides (TG)	Blood biochemistry	Week 12
Secondary	Triglycerides (TG) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	White blood cells (WBC)	Blood biochemistry	Week 0
Secondary	White blood cells (WBC)	Blood biochemistry	Week 12
Secondary	White blood cells (WBC) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Red blood cells (RBC)	Blood biochemistry	Week 0
Secondary	Red blood cells (RBC)	Blood biochemistry	Week 12
Secondary	Red blood cells (RBC) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Hemoglobin (HB)	Blood biochemistry	Week 0
Secondary	Hemoglobin (HB)	Blood biochemistry	Week 12
Secondary	Hemoglobin (HB) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Platelet count (PLT)	Blood biochemistry	Week 0
Secondary	Platelet count (PLT)	Blood biochemistry	Week 12
Secondary	Platelet count (PLT) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Hematocrit (HCT)	Blood biochemistry	Week 0
Secondary	Hematocrit (HCT)	Blood biochemistry	Week 12
Secondary	Hematocrit (HCT) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Mean corpuscular volume (MCV)	Blood biochemistry	Week 0
Secondary	Mean corpuscular volume (MCV)	Blood biochemistry	Week 12
Secondary	Mean corpuscular volume (MCV) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Mean corpuscular hemoglobin (MCH)	Blood biochemistry	Week 0
Secondary	Mean corpuscular hemoglobin (MCH)	Blood biochemistry	Week 12
Secondary	Mean corpuscular hemoglobin (MCH) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Mean corpuscular hemoglobin concentration (MCHC)	Blood biochemistry	Week 0
Secondary	Mean corpuscular hemoglobin concentration (MCHC)	Blood biochemistry	Week 12
Secondary	Mean corpuscular hemoglobin concentration (MCHC) (change)	Blood biochemistry	Change from week 0 to week 12
Secondary	Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Week 0
Secondary	Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Week 12
Secondary	Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Secondary	Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Week 0
Secondary	Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Week 12
Secondary	Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Secondary	Monocytes (MONO)	Blood biochemistry (WBC counts)	Week 0
Secondary	Monocytes (MONO)	Blood biochemistry (WBC counts)	Week 12
Secondary	Monocytes (MONO)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Secondary	Eosinophils (EOS)	Blood biochemistry (WBC counts)	Week 0
Secondary	Eosinophils (EOS)	Blood biochemistry (WBC counts)	Week 12
Secondary	Eosinophils (EOS)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Secondary	Basophils (BASO)	Blood biochemistry (WBC counts)	Week 0
Secondary	Basophils (BASO)	Blood biochemistry (WBC counts)	Week 12
Secondary	Basophils (BASO)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Secondary	Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-a)	Blood biochemistry (cytokines)	Week 0
Secondary	Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-a)	Blood biochemistry (cytokines)	Week 12
Secondary	Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-a) (change)	Blood biochemistry (cytokines)	Change from week 0 to week 12
Secondary	C-reactive protein (CRP)	Blood biochemistry	Week 0
Secondary	C-reactive protein (CRP)	Blood biochemistry	Week 12
Secondary	C-reactive protein (CRP) (change)	Blood biochemistry	Change from week 0 to week 12