Exploring the Effects of Probiotics on Workplace Related Stress Symptoms

NCT06381479 | Completed DMC

• 1 other identifier: B031
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

Conditions

Stress; Sleep Disorder

Keywords

probiotics

Outcome Measures

Primary Outcomes (1)

• Cortisol

  Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help: body respond to stress or danger increase body's metabolism of glucose control blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by body to ensure the balance is correct.

  From Baseline to 8 Weeks Assessed

Secondary Outcomes (15)

• Perceived Stress Scale (PSS)

  From Baseline to 8 Weeks Assessed

• Job Stress Scale

  From Baseline to 8 Weeks Assessed

• Overwork Survey

  From Baseline to 8 Weeks Assessed

• Insomnia Severity index (ISI)

  From Baseline to 8 Weeks Assessed

• The State Trait Anxiety Inventory (STAI)

  From Baseline to 8 Weeks Assessed

Study Arms (2)

probiotics

EXPERIMENTAL

Probiotic capsules

Dietary Supplement: probiotics

placebo

PLACEBO COMPARATOR

Placebo capsules

Dietary Supplement: placebo

Interventions

probiotics DIETARY_SUPPLEMENT

each capsule contains Lactiplantibacillus plantarum and Lacticaseibacillus paracasei, 2 caps daily use

probiotics

placebo DIETARY_SUPPLEMENT

The placebo capsule contains microcrystalline cellulose, 2 caps daily use.

placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20 to 60 years old
• Perceived Stress Scale (PSS) score is greater than or equal to 14 points

You may not qualify if:

• Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
• Those who are taking Chinese medicine or Western medicine to treat severe acute diseases
• Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
• Pregnant or breastfeeding
• Those who have participated in other interventional clinical studies in the past three months
• Who has conflict of interest with PI or unsuitable to participate in the research such as students directly supervised by the project host and those who are unable to read the consent form

Sponsors & Collaborators

• National Taiwan Sport University: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Graduate Institute of Sports Science, National Taiwan Sport University

Taoyuan District, 33301, Taiwan

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Research and Development Office

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 19, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 26, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

TW (1)