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

NCT03494725 | Completed Results

• 1 other identifier: DU01-2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotic; Gut-brain axis; Stress; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change of the Heart Rate (HR) in Response to the Trier Social Stress Test (TSST)

  Efficacy was defined as a lower increase in HR in response to the TSST following intervention with Lpc-37, compared to placebo.

  Continuous measurement starting 20 minutes before and ending 20 minutes after the TSST after 5 weeks of product intake. Mean values were calculated per group at seven-time windows before, during and after the TSST

Secondary Outcomes (32)

• Changes in Pre and Post Treatment STAI-state Scores

  Before and after 5 weeks of study product intake.

• Changes in Pre and Post Treatment Perceived Stress Scale (PSS) Scores

  Before and after 5 weeks of study product intake.

• Changes in Pre and Post Treatment DASS Depression Scores

  Before and after 5 weeks of study product intake.

• Changes in Pre and Post Treatment DASS Anxiety Scores

  Before and after 5 weeks of study product intake.

• Changes in Pre and Post Treatment DASS Stress Scores

  Before and after 5 weeks of study product intake.

Study Arms (2)

Lpc-37

ACTIVE COMPARATOR

Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37 1x 1 capsule in the morning for 5 weeks

Dietary Supplement: Lpc-37

Placebo

PLACEBO COMPARATOR

Placebo capsule manufactured to mimic Lpc-37 capsule 1x 1 capsule in the morning for 5 weeks

Dietary Supplement: Placebo

Interventions

Lpc-37 DIETARY_SUPPLEMENT

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

Lpc-37

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose, magnesium stearate, silicon dioxide

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary, written, informed consent to participate in the study
• Male or female aged between 18-45 years (inclusive)
• Body mass index (BMI) between 18.5 - 29.9 kg/m2
• Medical examination at baseline indicates they are healthy in the opinion of the investigator
• Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
• Agreement to comply with the protocol and study restrictions
• Available for all study visits
• Females of child-bearing potential required to provide a negative urine pregnancy test and to use contraceptives
• Easy access to internet

You may not qualify if:

• Self-reported diagnosis of one or more Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV axis 1 disorder(s), including but not limited to current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia
• Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic, neurodevelopmental or any condition which contraindicates, in the Investigator's judgement, entry to the study
• Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
• Currently taking (from day of screening onwards) medication or dietary supplements that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, omega-3 dietary supplements, non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter (OTC) sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, proton pump inhibitors, anti-histamines, pseudoephedrine, cortisone, beta-blockers)
• Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
• Daily consumption of concentrated sources of probiotics and/or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders)
• Pregnant or lactating female, or pregnancy planned during intervention period
• Not fluent in German
• Have self-reported dyslexia
• History of alcohol, drug, or medication abuse
• Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period
• Contraindication to any substance in the investigational product
• Hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
• Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
• Subjects having previously participated in the TSST

Sponsors & Collaborators

• Daacro: lead
• DuPont Nutrition and Health: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, Rhineland-Palatinate, 54296, Germany

Location

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  PMID: 33385020 DERIVED

Related Links

• daacro homepage

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Elaine Patterson, Ph. D.
• Organization: DuPont Nutrition and Biosciences

elaine.patterson@dupont.com

+358-40-4827-626

Study Officials

• Juliane Hellhammer, PhD

  Daacro GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 10, 2018
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)