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Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects

NCT03494725 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-25

Study results available
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Summary

The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can modulate stress and anxiety experienced by healthy subjects during and after an acute stressor compared to placebo. To measure stress and anxiety, markers of the hypothalamic-pituitary-adrenal (HPA) axis activity and questionnaires will be assessed before, during and after the Trier Social Stress Test (TSST). The results of this study indicate if the chosen study design is suitable to discover stress-related effects of probiotics.

Conditions

  • Healthy
  • Stress, Psychological

Interventions

DIETARY_SUPPLEMENT

Lpc-37

Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10\^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide

DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose, magnesium stearate, silicon dioxide

Sponsors & Collaborators

  • DuPont Nutrition and Health

    collaborator INDUSTRY

  • Daacro

    lead NETWORK

Principal Investigators

  • Juliane Hellhammer, PhD · Daacro GmbH & Co. KG

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2018-10-09
Completion
2018-10-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494725 on ClinicalTrials.gov