Psychophysiological Effects of Probiotic Supplementation

Not Applicable

Completed

• Conditions: Mild to Moderate Levels of Stress
• Interventions: Dietary Supplement: Experimental probiotic product; Other: Placebo comparator

• Registration Number: NCT05226520
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study Start: 2020-12-16
• Study First Submitted: 2021-12-06
• Primary Completion: 2021-12-22
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-07
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic NCC3001	Experimental probiotic product	Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks
Matched Placebo Comparator	Placebo comparator	Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Salivary cortisol level	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	Salivary cortisol levels (nmol/L) before and after stressor

Secondary Outcome Measures

Name	Time	Method
Probiotic in feces	Baseline and after 6 weeks treatment	Probiotic quantity in feces (genome copy number / million 16S copy number)
Mean heart rate variability	Baseline and after 6 weeks treatment	Mean heart rate variability in the time (ms) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Self-reported measures before and after the stressor (PANAS)	Baseline and after 6 weeks treatment	Positive and negative affect scores (1-50) computed with the Positive and Negative Affect Schedule (PANAS)
Self-reported measures before, during and after the stressor (VAS)	Baseline and after 6 weeks treatment	VAS scores in mm (0-100) for subjective perception of the stress induction
Self-reported endpoints from standard questionnaires (GSRS)	Baseline and after 6 weeks treatment	Scores from the Gastrointestinal Symptom-Rating Scale (GSRS): scores range from 1 to 7 and higher scores represent more discomfort
Cortisol level from waking saliva samples	Baseline and after 6 weeks treatment	Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking
Heart frequency	Baseline and after 6 weeks treatment	Heart frequency (Hz) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Self-reported measures before and after the stressor (STAI-6)	Baseline and after 6 weeks treatment	Likert scores (1-4) for 6 mood dimensions: calm, tense, upset, relaxed, content, worry from the State Trait Anxiety Inventory 6-item short form (STAI-6)
Mean skin conductance level	Baseline and after 6 weeks treatment	Mean skin conductance level (SCL, kΩ) measured continuously before, during and after the stressor by means of a portable a computer-based data acquisition system from Biopac, Inc
Self-reported endpoints from standard questionnaires (HADs)	Baseline and after 6 weeks treatment	Scores (0-21) of depression and anxiety computed from the Hospital Anxiety and Depression scale (HADs)
Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)	Baseline and after 6 weeks treatment	Sleep quality score from the Pittsburgh Sleep Quality Index questionnaire (score 0-21: the lower, the better sleep quality)
Self-reported endpoints from standard questionnaires (PSS)	Baseline and after 6 weeks treatment	Perceived stress score (0-56) computed from the Perceived Stress Scale (PSS)
Microbiome related metabolites in stool, blood and urine	Baseline and after 6 weeks treatment	Microbiome related metabolites in stool, blood and urine

Trial Locations

Locations (1)

Nestlé Research; 🇨🇭 Lausanne, Vaud, Switzerland