Psychophysiological Effects of Probiotic Supplementation

NCT05226520 | Completed

• 1 other identifier: 2004NRC
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Levels of Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Cortisol level from waking saliva samples

  Baseline and after 6 weeks treatment

• Mean heart rate variability

  Baseline and after 6 weeks treatment

• Heart frequency

  Baseline and after 6 weeks treatment

• Mean skin conductance level

  Baseline and after 6 weeks treatment

• Self-reported measures before and after the stressor (PANAS)

  Baseline and after 6 weeks treatment

Study Arms (2)

Probiotic NCC3001

EXPERIMENTAL

Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks

Dietary Supplement: Experimental probiotic product

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

Other: Placebo comparator

Interventions

Experimental probiotic product DIETARY_SUPPLEMENT

Probiotic supplementation

Probiotic NCC3001

Placebo comparator OTHER

Placebo

Matched Placebo Comparator

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestlé Research

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Study Officials

• Catherine Macé

  Nestlé Institute of Health Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unique coding
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 7, 2022
• Study Start: December 16, 2020
• Primary Completion: December 22, 2021
• Study Completion: May 31, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)