Psychophysiological Effects of Probiotic Supplementation

Nestlé

Status: Completed

Conditions: Mild to Moderate Levels of Stress

Treatments: Dietary Supplement: Experimental probiotic product; Other: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226520

2004NRC

Details and patient eligibility

About

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.

Full 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

Enrollment: 49 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

49 participants in 2 patient groups, including a placebo group

Probiotic NCC3001

Experimental group

Description:

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

Treatment:

Dietary Supplement: Experimental probiotic product

Matched Placebo Comparator

Placebo Comparator group

Description:

Sachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks

Treatment:

Other: Placebo comparator