Clinical trial NCT05840978: Effect of Probiotics on Stress in Young Adults
Official title: Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
Mental Health
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.

At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.

At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator
* Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household

Primary outcomes:
measure: Perceived stress
timeFrame: Before, during, and after TSST at visit 2 (week 8)
Secondary outcomes:
measure: STAI score
timeFrame: Before and after TSST at visit 2 (week 8)
measure: PSS score
timeFrame: baseline and week 8
measure: STAI score
timeFrame: baseline and week 8
measure: Anxiety
timeFrame: Before, during, and after TSST at visit 2 (week 8)
measure: Emotional insecurity
timeFrame: Before, during, and after TSST at visit 2 (week 8)
measure: Exhaustion
timeFrame: Before, during, and after TSST at visit 2 (week 8)
Other outcomes:
measure: Cortisol
timeFrame: Before, during, and after TSST at visit 2 (week 8)
measure: Inflammatory biomarker IL-6
timeFrame: baseline and week 8
measure: Inflammatory biomarker IL-10
timeFrame: baseline and week 8
Locations:
city: Cork
country: Ireland
facility: Atlantia clinical trials
Study officials:
affiliation: Atlantia Clinical Trials Ltd
name: Timothy Dinan, Professor
role: PRINCIPAL_INVESTIGATOR
References: