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Probiotic Intervention for Acute Stress

NCT03284905 — Not applicable, Completed, 70 participants, Probi AB

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RegistryNCT03284905
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment70 (Actual)
SponsorProbi AB (Industry)
ConditionsStress
InterventionsProbiotic supplement, Placebo supplement (Dietary supplement)
Datesstart 2017-10-02, primary completion 2018-04-04, completion 2018-04-04, first posted 2017-09-15, last updated 2019-03-20
Locations1 site in Sweden

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-Summary

Efficacy of probiotics on acute stress

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+Arms and interventions

ArmTypeInterventionsDescription
ProbioticsActive comparatorDietary Supplement: Probiotic supplement
PlaceboPlacebo comparatorDietary Supplement: Placebo supplement
  • Probiotic supplement (Dietary supplement): Capsule containing freeze dried probiotic bacteria together with maize starch
  • Placebo supplement (Dietary supplement): Capsule containing maize starch

+Outcome measures

Primary outcomes

  • Reduction of the cortisol level during acute stress [2.5 hours]

+Eligibility

Sex: All, ages: 19 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* 19-35 years
* SMBQ-score ≥3.75
* Understand Swedish in spoken and written terms
* Willing and able to give written informed consent for participating in the study
* Intake of probiotics within two weeks prior to the start of the study

Exclusion Criteria:

* BMI> 30
* Pregnant
* Antibiotic treatment in the last three months
* Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness
* Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment

+Locations (1)

FacilityCityCountryStatus
Department of Food Technology, Engineering and Nutrition, Lund UniversityLundSweden

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