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

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 Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Placebo; Dietary supplement: Bifidobacterium longum OLP-01

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Department of rehabilitation, ShuangHo Hospital
  • Taipei city, Taiwan
    • Department of rehabilitation, Taipei Medical University Hospital
  • Taipei city, Taiwan
    • Department of rehabilitation, WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Subjects in placebo group will treat with placebo.	Other: Placebo; Subjects in placebo group will supplement with placebo powder per day for 12 weeks.
Experimental: Supplement group; Subjects in supplement group will treat with Bifidobacterium longum OLP-01.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal cognitive assessment (MoCA)	Cognitive function	Week 0
Montreal cognitive assessment (MoCA)	Cognitive function	Week 12
Montreal cognitive assessment (MoCA) (change)	Cognitive function	Change from week 0 to week 12
Trail-making test A and B (TMT A and B)	Cognitive function	Week 0
Trail-making test A and B (TMT A and B)	Cognitive function	Week 12
Trail-making test A and B (TMT A and B) (change)	Cognitive function	Change from week 0 to week 12
Stroop color naming test	Cognitive function	Week 0
Stroop color naming test	Cognitive function	Week 12
Stroop color naming test (change)	Cognitive function	Change from week 0 to week 12
Timed up and go test (TUGT)	Exercise performance	Week 0
Timed up and go test (TUGT)	Exercise performance	Week 12
Timed up and go test (TUGT) (change)	Exercise performance	Change from week 0 to week 12
6-min walking test	Exercise performance	Week 0
6-min walking test	Exercise performance	Week 12
6-min walking test (change)	Exercise performance	Change from week 0 to week 12
Albumin	Nutritional Status	Week 0
Albumin	Nutritional Status	Week 12
Albumin (change)	Nutritional Status	Change from week 0 to week 12
Pre-albumin	Nutritional Status	Week 0
Pre-albumin	Nutritional Status	Week 12
Pre-albumin (change)	Nutritional Status	Change from week 0 to week 12
Transferrin	Nutritional Status	Week 0
Transferrin	Nutritional Status	Week 12
Transferrin (change)	Nutritional Status	Change from week 0 to week 12
3-day dietary record	Nutritional Status	Week 0
3-day dietary record	Nutritional Status	Week 12
3-day dietary record (change)	Nutritional Status	Change from week 0 to week 12
Mini-nutritional assessment (MNA)	Nutritional Status	Week 0
Mini-nutritional assessment (MNA)	Nutritional Status	Week 12
Mini-nutritional assessment (MNA) (change)	Nutritional Status	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.	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.	Week 12
α-diversity	Gut microbiota	Week 0
α-diversity	Gut microbiota	Week 12
β-diversity	Gut microbiota	Week 0
β-diversity	Gut microbiota	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Anthropometry data	Week 0
Height	Anthropometry data	Week 12
Height (change)	Anthropometry data	Change from week 0 to week 12
Weight	Anthropometry data	Week 0
Weight	Anthropometry data	Week 12
Weight (change)	Anthropometry data	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	Week 0
Body mass index (BMI)	Anthropometry data Weight and height will be combined to report BMI in kg/m^2	Week 12
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
Waist circumference	Anthropometry data	Week 0
Waist circumference	Anthropometry data	Week 12
Waist circumference (change)	Anthropometry data	Change from week 0 to week 12
Mid-upper arm circumference	Anthropometry data	Week 0
Mid-upper arm circumference	Anthropometry data	Week 12
Mid-upper arm circumference (change)	Anthropometry data	Change from week 0 to week 12
Hip circumference	Anthropometry data	Week 0
Hip circumference	Anthropometry data	Week 12
Hip circumference (change)	Anthropometry data	Change from week 0 to week 12
Calf circumference	Anthropometry data	Week 0
Calf circumference	Anthropometry data	Week 12
Calf circumference (change)	Anthropometry data	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	Week 0
Waist to hip ratio	Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio	Week 12
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
Muscle mass	Body composition	Week 0
Muscle mass	Body composition	Week 12
Muscle mass (change)	Body composition	Change from week 0 to week 12
Body fat	Body composition	Week 0
Body fat	Body composition	Week 12
Body fat (change)	Body composition	Change from week 0 to week 12
Basal metabolic rate	Body composition	Week 0
Basal metabolic rate	Body composition	Week 12
Basal metabolic rate (change)	Body composition	Change from week 0 to week 12
Blood pressure	Clinical data	Week 0
Blood pressure	Clinical data	Week 12
Blood pressure (change)	Clinical data	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	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	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.	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.	Week 12
Fasting blood glucose	Blood biochemistry	Week 0
Fasting blood glucose	Blood biochemistry	Week 12
Fasting blood glucose (change)	Blood biochemistry	Change from week 0 to week 12
Glycated hemoglobin A1c (HbA1c)	Blood biochemistry	Week 0
Glycated hemoglobin A1c (HbA1c)	Blood biochemistry	Week 12
Glycated hemoglobin A1c (HbA1c) (change)	Blood biochemistry	Change from week 0 to week 12
Total cholesterol (TC)	Blood biochemistry	Week 0
Total cholesterol (TC)	Blood biochemistry	Week 12
Total cholesterol (TC) (change)	Blood biochemistry	Change from week 0 to week 12
High density lipoprotein cholesterol (HDL-C)	Blood biochemistry	Week 0
High density lipoprotein cholesterol (HDL-C)	Blood biochemistry	Week 12
High density lipoprotein cholesterol (HDL-C) (change)	Blood biochemistry	Change from week 0 to week 12
Low density lipoprotein cholesterol (LDL-C)	Blood biochemistry	Week 0
Low density lipoprotein cholesterol (LDL-C)	Blood biochemistry	Week 12
Low density lipoprotein cholesterol (LDL-C) (change)	Blood biochemistry	Change from week 0 to week 12
Triglycerides (TG)	Blood biochemistry	Week 0
Triglycerides (TG)	Blood biochemistry	Week 12
Triglycerides (TG) (change)	Blood biochemistry	Change from week 0 to week 12
White blood cells (WBC)	Blood biochemistry	Week 0
White blood cells (WBC)	Blood biochemistry	Week 12
White blood cells (WBC) (change)	Blood biochemistry	Change from week 0 to week 12
Red blood cells (RBC)	Blood biochemistry	Week 0
Red blood cells (RBC)	Blood biochemistry	Week 12
Red blood cells (RBC) (change)	Blood biochemistry	Change from week 0 to week 12
Hemoglobin (HB)	Blood biochemistry	Week 0
Hemoglobin (HB)	Blood biochemistry	Week 12
Hemoglobin (HB) (change)	Blood biochemistry	Change from week 0 to week 12
Platelet count (PLT)	Blood biochemistry	Week 0
Platelet count (PLT)	Blood biochemistry	Week 12
Platelet count (PLT) (change)	Blood biochemistry	Change from week 0 to week 12
Hematocrit (HCT)	Blood biochemistry	Week 0
Hematocrit (HCT)	Blood biochemistry	Week 12
Hematocrit (HCT) (change)	Blood biochemistry	Change from week 0 to week 12
Mean corpuscular volume (MCV)	Blood biochemistry	Week 0
Mean corpuscular volume (MCV)	Blood biochemistry	Week 12
Mean corpuscular volume (MCV) (change)	Blood biochemistry	Change from week 0 to week 12
Mean corpuscular hemoglobin (MCH)	Blood biochemistry	Week 0
Mean corpuscular hemoglobin (MCH)	Blood biochemistry	Week 12
Mean corpuscular hemoglobin (MCH) (change)	Blood biochemistry	Change from week 0 to week 12
Mean corpuscular hemoglobin concentration (MCHC)	Blood biochemistry	Week 0
Mean corpuscular hemoglobin concentration (MCHC)	Blood biochemistry	Week 12
Mean corpuscular hemoglobin concentration (MCHC) (change)	Blood biochemistry	Change from week 0 to week 12
Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Week 0
Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Week 12
Neutrophils (NEUT)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Week 0
Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Week 12
Lymphocytes (LYM)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Monocytes (MONO)	Blood biochemistry (WBC counts)	Week 0
Monocytes (MONO)	Blood biochemistry (WBC counts)	Week 12
Monocytes (MONO)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Eosinophils (EOS)	Blood biochemistry (WBC counts)	Week 0
Eosinophils (EOS)	Blood biochemistry (WBC counts)	Week 12
Eosinophils (EOS)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Basophils (BASO)	Blood biochemistry (WBC counts)	Week 0
Basophils (BASO)	Blood biochemistry (WBC counts)	Week 12
Basophils (BASO)	Blood biochemistry (WBC counts)	Change from week 0 to week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)	Blood biochemistry (cytokines)	Week 0
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)	Blood biochemistry (cytokines)	Week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change)	Blood biochemistry (cytokines)	Change from week 0 to week 12
C-reactive protein (CRP)	Blood biochemistry	Week 0
C-reactive protein (CRP)	Blood biochemistry	Week 12
C-reactive protein (CRP) (change)	Blood biochemistry	Change from week 0 to week 12

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Chao Jane C-J, PhD, Taipei Medical University, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Anticipated): February 11, 2023
• Study Completion (Anticipated): February 11, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Cognitive function; Gut microbiota; Nutritional status; Exercise performance; Bifidobacterium longum OLP-01
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: N202011038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No