Psychophysiological Effects of Probiotic Supplementation

NCT ID: NCT05226520

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2022-05-31

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

Conditions

Mild to Moderate Levels of Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic NCC3001

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

Group Type: EXPERIMENTAL

Experimental probiotic product

Intervention Type: DIETARY_SUPPLEMENT

Probiotic supplementation

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

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: OTHER

Placebo

Interventions

Experimental probiotic product

Probiotic supplementation

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparator

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Macé

Role: STUDY_DIRECTOR

Nestlé Institute of Health Science

Locations

Nestlé Research

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2004NRC

Identifier Type: -

Identifier Source: org_study_id