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

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.

Conditions

• Stroke

Interventions

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.

Sponsors & Collaborators

• Taipei Medical University

  lead OTHER

Principal Investigators

• Chao Jane C-J, PhD · Taipei Medical University, Taiwan, R.O.C.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-12

Primary Completion

2023-02-11

Completion

2023-02-11

Countries

• Taiwan

Study Locations