Psychophysiological Effects of Probiotic Supplementation (NCT05226520) | Clinical Trial Compass
CompletedNot Applicable
Psychophysiological Effects of Probiotic Supplementation
Switzerland49 participantsStarted 2020-12-16
Plain-language 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.
Who can participate
Age range25 Years – 65 Years
SexALL
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Inclusion criteria
✓. Ability to understand and sign the informed consent
✓. Healthy adult men and/or women aged 25 to 65 years old
✓. 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)
✓. Proficiency in French and/or English
✓. Normal visual acuity and hearing with or without correction (self-reported)
✓. BMI in the range of 18.5 to 29.9 kg/m2
Exclusion criteria
✕. Diagnosed food allergies
✕. Currently participating or having recently participated in a clinical study with products potentially interfering with the results as judged by the investigator
✕. Organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids
✕. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
✕. 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
What they're measuring
1
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