Effect of Probiotics on Stress in Young Adults

NCT05840978 | Completed

• 1 other identifier: HND-MH-052
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).

Conditions

Stress

Keywords

Stress; Mental Health

Outcome Measures

Primary Outcomes (1)

• Perceived stress

  Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST

  Before, during, and after TSST at visit 2 (week 8)

Secondary Outcomes (6)

• STAI score

  Before and after TSST at visit 2 (week 8)

• PSS score

  baseline and week 8

• STAI score

  baseline and week 8

• Anxiety

  Before, during, and after TSST at visit 2 (week 8)

• Emotional insecurity

  Before, during, and after TSST at visit 2 (week 8)

Other Outcomes (3)

• Cortisol

  Before, during, and after TSST at visit 2 (week 8)

• Inflammatory biomarker IL-6

  baseline and week 8

• Inflammatory biomarker IL-10

  baseline and week 8

Study Arms (3)

Probiotics combined strains

EXPERIMENTAL

Probiotics combined strains administered as oral capsules once daily

Dietary Supplement: Probiotics

Probiotics single strain

EXPERIMENTAL

Probiotics single strain administered as oral capsules once daily

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Placebo capsule administered orally once daily

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

Oral capsules

Probiotics combined strains; Probiotics single strain

Placebo DIETARY_SUPPLEMENT

Oral capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to give informed e-consent
• Be between 18 and 45 years old, inclusive
• In general good health, as determined by the investigator
• Have a BMI of ≥18.5 and \<30.0 kg/m2
• Willing to consume the study product daily for the duration of the study and comply with the study procedures
• Have moderate stress, as measured on the Cohen's Perceived Stress Scale, with a score between 14 and 26 (inclusive)
• Be able to communicate well with the Investigator, to understand and comply with the study requirements and be judged suitable for the study in the opinion of the investigator

You may not qualify if:

• Scores ≥10 on General Anxiety Disorder 7 item (GAD-7) and Patient Health Questionnaire 9 item (PHQ-9)
• Have a history of in-person public speaking or presenting to large groups regularly (≥2 times/year) in the past 12 months
• Have a known major stressful life event occurring (current or upcoming) during the study
• Participants who have a significant illness or condition which may, in the opinion of the investigator impact their ability to participate in the study or impact the study outcomes (e.g. any chronic disease, including hypertension, type 1 or 2 diabetes, cardiovascular diseases, gastrointestinal disorders, celiac disease, and IBD)
• Any disease, that by the investigator's judgement, could interfere with the intestinal barrier function
• Use of oral or systemic (topical allowed) immunosuppressant drugs, antibiotics, steroids, etc. within the one month before screening
• Consumption of probiotic supplements that contain live bacteria in the 4 weeks before the screening
• Regular use of anti-inflammatory drugs such as aspirin or ibuprofen (\>200mg/24 hours)
• Food allergy or hypersensitivity to any component of the product
• Heavy alcohol use or recent history (within one year) of illicit drug use
• Participants who work night shifts
• Participation in other clinical trials or studies in the last month
• Desire and/or plans on changing current diet and/or exercise regime during the participation of this study
• Participants who are pregnant or wish to become pregnant during the study
• Participants who are lactating and/or currently breastfeeding

Sponsors & Collaborators

• Chr Hansen: lead

Study Sites (1)

Atlantia clinical trials

Cork, Ireland

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Timothy Dinan, Professor

  Atlantia Clinical Trials Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 3, 2023
• Study Start: April 5, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)