Psychophysiological Effects of Probiotic Supplementation

Effect of 6-week Probiotic Supplementation on Stress-related Parameters in Healthy Adults With Different Levels of Stress

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Levels of Stress
• Intervention / Treatment: Dietary supplement: Experimental probiotic product; Other: Placebo comparator

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestlé Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic NCC3001; Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks	Dietary supplement: Experimental probiotic product; Probiotic supplementation
Placebo Comparator: Matched Placebo Comparator; Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks	Other: Placebo comparator; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary cortisol level	Salivary cortisol levels (nmol/L) before and after stressor	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol level from waking saliva samples	Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking	Baseline and after 6 weeks treatment
Mean heart rate variability	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	Baseline and after 6 weeks treatment
Heart frequency	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	Baseline and after 6 weeks treatment
Mean skin conductance level	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	Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (PANAS)	Positive and negative affect scores (1-50) computed with the Positive and Negative Affect Schedule (PANAS)	Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (STAI-6)	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)	Baseline and after 6 weeks treatment
Self-reported measures before, during and after the stressor (VAS)	VAS scores in mm (0-100) for subjective perception of the stress induction	Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (PSS)	Perceived stress score (0-56) computed from the Perceived Stress Scale (PSS)	Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (HADs)	Scores (0-21) of depression and anxiety computed from the Hospital Anxiety and Depression scale (HADs)	Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (GSRS)	Scores from the Gastrointestinal Symptom-Rating Scale (GSRS): scores range from 1 to 7 and higher scores represent more discomfort	Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)	Sleep quality score from the Pittsburgh Sleep Quality Index questionnaire (score 0-21: the lower, the better sleep quality)	Baseline and after 6 weeks treatment
Probiotic in feces	Probiotic quantity in feces (genome copy number / million 16S copy number)	Baseline and after 6 weeks treatment
Microbiome related metabolites in stool, blood and urine	Microbiome related metabolites in stool, blood and urine	Baseline and after 6 weeks treatment

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Catherine Macé, Nestlé Institute of Health Science

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2004NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No