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

NCT ID: NCT05477732

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2023-02-11

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo group

Subjects in placebo group will treat with placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subjects in placebo group will supplement with placebo powder per day for 12 weeks.

Supplement group

Subjects in supplement group will treat with Bifidobacterium longum OLP-01.

Group Type: EXPERIMENTAL

Bifidobacterium longum OLP-01

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Subjects in placebo group will supplement with placebo powder per day for 12 weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao Jane C-J, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University, Taiwan, R.O.C.

Locations

Department of rehabilitation, ShuangHo Hospital

New Taipei City, , Taiwan

Department of rehabilitation, Taipei Medical University Hospital

Taipei, , Taiwan

Department of rehabilitation, WanFang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202011038

Identifier Type: -

Identifier Source: org_study_id