Effect of Probiotics on Stress in Young Adults

Stress Clinical Trial

Official title:

Effect of Probiotics on Stress in Young Adults: a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840978
• Other study ID #: HND-MH-052
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stress

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)