Clinical trial NCT05226520: Psychophysiological Effects of Probiotic Supplementation
Official title: Effect of 6-week Probiotic Supplementation on Stress-related Parameters in Healthy Adults With Different Levels of Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Levels of Stress
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel
Primary purpose: OTHER

Brief summary: This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.

Detailed description: The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.

The objectives is three:

* Measure the effects of a 6-week supplementation with NCC3001 on psychological and physiological parameters in response to an acute experimental stress;
* Measure the effects of a 6-week supplementation with NCC3001 on chronic stress level, gastro-intestinal symptoms and sleep quality;
* Explore changes in the profiles of biological parameters associated with ingestion of NCC3001; including changes in hormones, neurotransmitters, circulating immune and microbiome-derived molecules and changes in the microbiome itself

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and sign the informed consent
2. Healthy adult men and/or women aged 25 to 65 years old
3. Mild to moderate stress, defined as a score in the range of 15 to 25 on the validated Depression, Anxiety and Stress Scale (DASS-42)
4. Proficiency in French and/or English
5. Normal visual acuity and hearing with or without correction (self-reported)
6. BMI in the range of 18.5 to 29.9 kg/m2

Exclusion Criteria:

1. Diagnosed food allergies
2. Currently participating or having recently participated in a clinical study with products potentially interfering with the results as judged by the investigator
3. Organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids
4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
5. Concurrent diagnosed systemic chronic disease (e.g., endocrine, cardiovascular, metabolic, liver, celiac)
6. Willing to avoid the consumption of probiotic-containing products (including yogurts containing probiotics) i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus or Saccharomyces for the 2 weeks prior to randomization visit
7. Willing to avoid the use of antibiotics in the 4 weeks prior to randomization visit
8. Adherence to an overly unbalanced diet such as vegan, paleo, ketogenic, low carbohydrate, raw diets
9. Conditions that may affect mood

Primary outcomes:
measure: Salivary cortisol level
timeFrame: Before the stressor (time-point -20 minutes) and after the stressor (time-point +0 min, time-point +5 min, time-point +10 min, time-point +20 min, time-point +30 min, time-point +40 min) at both baseline and after 6 weeks of treatment
Secondary outcomes:
measure: Cortisol level from waking saliva samples
timeFrame: Baseline and after 6 weeks treatment
measure: Mean heart rate variability
timeFrame: Baseline and after 6 weeks treatment
measure: Heart frequency
timeFrame: Baseline and after 6 weeks treatment
measure: Mean skin conductance level
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported measures before and after the stressor (PANAS)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported measures before and after the stressor (STAI-6)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported measures before, during and after the stressor (VAS)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported endpoints from standard questionnaires (PSS)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported endpoints from standard questionnaires (HADs)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported endpoints from standard questionnaires (GSRS)
timeFrame: Baseline and after 6 weeks treatment
measure: Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)
timeFrame: Baseline and after 6 weeks treatment
measure: Probiotic in feces
timeFrame: Baseline and after 6 weeks treatment
measure: Microbiome related metabolites in stool, blood and urine
timeFrame: Baseline and after 6 weeks treatment
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Research
state: Vaud
Study officials:
affiliation: Nestlé Institute of Health Science
name: Catherine Macé
role: STUDY_DIRECTOR
References: