Clinical trial NCT05477732: Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients
Official title: Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Bifidobacterium longum OLP-01
Stroke
Cognitive function
Exercise performance
Nutritional status
Gut microbiota
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montreal cognitive assessment (MoCA)
timeFrame: Week 0
measure: Montreal cognitive assessment (MoCA)
timeFrame: Week 12
measure: Montreal cognitive assessment (MoCA) (change)
timeFrame: Change from week 0 to week 12
measure: Trail-making test A and B (TMT A and B)
timeFrame: Week 0
measure: Trail-making test A and B (TMT A and B)
timeFrame: Week 12
measure: Trail-making test A and B (TMT A and B) (change)
timeFrame: Change from week 0 to week 12
measure: Stroop color naming test
timeFrame: Week 0
measure: Stroop color naming test
timeFrame: Week 12
measure: Stroop color naming test (change)
timeFrame: Change from week 0 to week 12
measure: Timed up and go test (TUGT)
timeFrame: Week 0
measure: Timed up and go test (TUGT)
timeFrame: Week 12
measure: Timed up and go test (TUGT) (change)
timeFrame: Change from week 0 to week 12
measure: 6-min walking test
timeFrame: Week 0
measure: 6-min walking test
timeFrame: Week 12
measure: 6-min walking test (change)
timeFrame: Change from week 0 to week 12
measure: Albumin
timeFrame: Week 0
measure: Albumin
timeFrame: Week 12
measure: Albumin (change)
timeFrame: Change from week 0 to week 12
measure: Pre-albumin
timeFrame: Week 0
measure: Pre-albumin
timeFrame: Week 12
measure: Pre-albumin (change)
timeFrame: Change from week 0 to week 12
measure: Transferrin
timeFrame: Week 0
measure: Transferrin
timeFrame: Week 12
measure: Transferrin (change)
timeFrame: Change from week 0 to week 12
measure: 3-day dietary record
timeFrame: Week 0
measure: 3-day dietary record
timeFrame: Week 12
measure: 3-day dietary record (change)
timeFrame: Change from week 0 to week 12
measure: Mini-nutritional assessment (MNA)
timeFrame: Week 0
measure: Mini-nutritional assessment (MNA)
timeFrame: Week 12
measure: Mini-nutritional assessment (MNA) (change)
timeFrame: Change from week 0 to week 12
measure: Relative abundance
timeFrame: Week 0
measure: Relative abundance
timeFrame: Week 12
measure: α-diversity
timeFrame: Week 0
measure: α-diversity
timeFrame: Week 12
measure: β-diversity
timeFrame: Week 0
measure: β-diversity
timeFrame: Week 12
Secondary outcomes:
measure: Height
timeFrame: Week 0
measure: Height
timeFrame: Week 12
measure: Height (change)
timeFrame: Change from week 0 to week 12
measure: Weight
timeFrame: Week 0
measure: Weight
timeFrame: Week 12
measure: Weight (change)
timeFrame: Change from week 0 to week 12
measure: Body mass index (BMI)
timeFrame: Week 0
measure: Body mass index (BMI)
timeFrame: Week 12
measure: Body mass index (BMI) (change)
timeFrame: Change from week 0 to week 12
measure: Waist circumference
timeFrame: Week 0
measure: Waist circumference
timeFrame: Week 12
measure: Waist circumference (change)
timeFrame: Change from week 0 to week 12
measure: Mid-upper arm circumference
timeFrame: Week 0
measure: Mid-upper arm circumference
timeFrame: Week 12
measure: Mid-upper arm circumference (change)
timeFrame: Change from week 0 to week 12
measure: Hip circumference
timeFrame: Week 0
measure: Hip circumference
timeFrame: Week 12
measure: Hip circumference (change)
timeFrame: Change from week 0 to week 12
measure: Calf circumference
timeFrame: Week 0
measure: Calf circumference
timeFrame: Week 12
measure: Calf circumference (change)
timeFrame: Change from week 0 to week 12
measure: Waist to hip ratio
timeFrame: Week 0
measure: Waist to hip ratio
timeFrame: Week 12
measure: Waist to hip ratio (change)
timeFrame: Change from week 0 to week 12
measure: Muscle mass
timeFrame: Week 0
measure: Muscle mass
timeFrame: Week 12
measure: Muscle mass (change)
timeFrame: Change from week 0 to week 12
measure: Body fat
timeFrame: Week 0
measure: Body fat
timeFrame: Week 12
measure: Body fat (change)
timeFrame: Change from week 0 to week 12
measure: Basal metabolic rate
timeFrame: Week 0
measure: Basal metabolic rate
timeFrame: Week 12
measure: Basal metabolic rate (change)
timeFrame: Change from week 0 to week 12
measure: Blood pressure
timeFrame: Week 0
measure: Blood pressure
timeFrame: Week 12
measure: Blood pressure (change)
timeFrame: Change from week 0 to week 12
measure: Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
timeFrame: Week 0
measure: Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
timeFrame: Week 12
measure: Medical history, drug use and life style questionnaires
timeFrame: Week 0
measure: Medical history, drug use and life style questionnaires
timeFrame: Week 12
measure: Fasting blood glucose
timeFrame: Week 0
measure: Fasting blood glucose
timeFrame: Week 12
measure: Fasting blood glucose (change)
timeFrame: Change from week 0 to week 12
measure: Glycated hemoglobin A1c (HbA1c)
timeFrame: Week 0
measure: Glycated hemoglobin A1c (HbA1c)
timeFrame: Week 12
measure: Glycated hemoglobin A1c (HbA1c) (change)
timeFrame: Change from week 0 to week 12
measure: Total cholesterol (TC)
timeFrame: Week 0
measure: Total cholesterol (TC)
timeFrame: Week 12
measure: Total cholesterol (TC) (change)
timeFrame: Change from week 0 to week 12
measure: High density lipoprotein cholesterol (HDL-C)
timeFrame: Week 0
measure: High density lipoprotein cholesterol (HDL-C)
timeFrame: Week 12
measure: High density lipoprotein cholesterol (HDL-C) (change)
timeFrame: Change from week 0 to week 12
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Week 0
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Week 12
measure: Low density lipoprotein cholesterol (LDL-C) (change)
timeFrame: Change from week 0 to week 12
measure: Triglycerides (TG)
timeFrame: Week 0
measure: Triglycerides (TG)
timeFrame: Week 12
measure: Triglycerides (TG) (change)
timeFrame: Change from week 0 to week 12
measure: White blood cells (WBC)
timeFrame: Week 0
measure: White blood cells (WBC)
timeFrame: Week 12
measure: White blood cells (WBC) (change)
timeFrame: Change from week 0 to week 12
measure: Red blood cells (RBC)
timeFrame: Week 0
measure: Red blood cells (RBC)
timeFrame: Week 12
measure: Red blood cells (RBC) (change)
timeFrame: Change from week 0 to week 12
measure: Hemoglobin (HB)
timeFrame: Week 0
measure: Hemoglobin (HB)
timeFrame: Week 12
measure: Hemoglobin (HB) (change)
timeFrame: Change from week 0 to week 12
measure: Platelet count (PLT)
timeFrame: Week 0
measure: Platelet count (PLT)
timeFrame: Week 12
measure: Platelet count (PLT) (change)
timeFrame: Change from week 0 to week 12
measure: Hematocrit (HCT)
timeFrame: Week 0
measure: Hematocrit (HCT)
timeFrame: Week 12
measure: Hematocrit (HCT) (change)
timeFrame: Change from week 0 to week 12
measure: Mean corpuscular volume (MCV)
timeFrame: Week 0
measure: Mean corpuscular volume (MCV)
timeFrame: Week 12
measure: Mean corpuscular volume (MCV) (change)
timeFrame: Change from week 0 to week 12
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: Week 0
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: Week 12
measure: Mean corpuscular hemoglobin (MCH) (change)
timeFrame: Change from week 0 to week 12
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Week 0
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Week 12
measure: Mean corpuscular hemoglobin concentration (MCHC) (change)
timeFrame: Change from week 0 to week 12
measure: Neutrophils (NEUT)
timeFrame: Week 0
measure: Neutrophils (NEUT)
timeFrame: Week 12
measure: Neutrophils (NEUT)
timeFrame: Change from week 0 to week 12
measure: Lymphocytes (LYM)
timeFrame: Week 0
measure: Lymphocytes (LYM)
timeFrame: Week 12
measure: Lymphocytes (LYM)
timeFrame: Change from week 0 to week 12
measure: Monocytes (MONO)
timeFrame: Week 0
measure: Monocytes (MONO)
timeFrame: Week 12
measure: Monocytes (MONO)
timeFrame: Change from week 0 to week 12
measure: Eosinophils (EOS)
timeFrame: Week 0
measure: Eosinophils (EOS)
timeFrame: Week 12
measure: Eosinophils (EOS)
timeFrame: Change from week 0 to week 12
measure: Basophils (BASO)
timeFrame: Week 0
measure: Basophils (BASO)
timeFrame: Week 12
measure: Basophils (BASO)
timeFrame: Change from week 0 to week 12
measure: Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
timeFrame: Week 0
measure: Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
timeFrame: Week 12
measure: Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change)
timeFrame: Change from week 0 to week 12
measure: C-reactive protein (CRP)
timeFrame: Week 0
measure: C-reactive protein (CRP)
timeFrame: Week 12
measure: C-reactive protein (CRP) (change)
timeFrame: Change from week 0 to week 12
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of rehabilitation, ShuangHo Hospital
city: Taipei city
country: Taiwan
facility: Department of rehabilitation, Taipei Medical University Hospital
city: Taipei city
country: Taiwan
facility: Department of rehabilitation, WanFang Hospital
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Chao Jane C-J, PhD
role: PRINCIPAL_INVESTIGATOR
References: