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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05840978
Other study ID # HND-MH-052
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2023
Est. completion date December 11, 2023

Study information

Verified date December 2023
Source Chr Hansen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date December 11, 2023
Est. primary completion date December 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotics
Oral capsules
Placebo
Oral capsules

Locations

Country Name City State
Ireland Atlantia clinical trials Cork

Sponsors (1)

Lead Sponsor Collaborator
Chr Hansen

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Other Cortisol Salivary cortisol levels in response to TSST Before, during, and after TSST at visit 2 (week 8)
Other Inflammatory biomarker IL-6 Blood inflammatory biomarkers from baseline to week 8 baseline and week 8
Other Inflammatory biomarker IL-10 Blood inflammatory biomarkers from baseline to week 8 baseline and week 8
Primary 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 STAI score Change in State-Trait Anxiety Index (STAI) in response to TSST. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. Before and after TSST at visit 2 (week 8)
Secondary PSS score Change in Cohen's Perceived Stress Scale (PSS) from baseline to week 8. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. baseline and week 8
Secondary STAI score Change in State-Trait Anxiety Index (STAI) from baseline to week 8. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. baseline and week 8
Secondary Anxiety Change in Anxiety Visual Analog Scale (VAS) in response to TSST Before, during, and after TSST at visit 2 (week 8)
Secondary Emotional insecurity Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST Before, during, and after TSST at visit 2 (week 8)
Secondary Exhaustion Change in Exhaustion Visual Analog Scale (VAS) in response to TSST Before, during, and after TSST at visit 2 (week 8)
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