Status:
COMPLETED
Psychophysiological Effects of Probiotic Supplementation
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Mild to Moderate Levels of Stress
Eligibility:
All Genders
25-65 years
Phase:
NA
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 indiv...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
- Concurrent diagnosed systemic chronic disease (e.g., endocrine, cardiovascular, metabolic, liver, celiac)
- 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
- Willing to avoid the use of antibiotics in the 4 weeks prior to randomization visit
- Adherence to an overly unbalanced diet such as vegan, paleo, ketogenic, low carbohydrate, raw diets
- Conditions that may affect mood
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05226520
Start Date
December 16 2020
End Date
May 31 2022
Last Update
July 15 2022
Active Locations (1)
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1
Nestlé Research
Lausanne, Canton of Vaud, Switzerland, 1000