Mild to Moderate Levels of StressNCT05226520
Psychophysiological Effects of Probiotic Supplementation
A study testing Experimental probiotic product in people with Mild to Moderate Levels of Stress, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Levels of Stress
- What is being tested?
- Experimental probiotic product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Dec 2020to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Experimental probiotic product, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental probiotic productDietary supplement
Probiotic supplementation
Placebo comparatorOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic NCC3001 | Experimental | Sachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks Receives: 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 Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol level
Salivary cortisol levels (nmol/L) before and after stressor
Measured: 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
Cortisol level (nmol/L) from waking saliva samples collected 0, 15, 30, 45, 60 min after waking
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline and after 6 weeks treatment
Probiotic in feces
Probiotic quantity in feces (genome copy number / million 16S copy number)
Measured: Baseline and after 6 weeks treatment
Microbiome related metabolites in stool, blood and urine
Microbiome related metabolites in stool, blood and urine
Measured: Baseline and after 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start16 Dec 2020
- Primary completion22 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Levels of StressStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Macé, Study director, Nestlé Institute of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226520
- Sponsor's protocol ID
- 2004NRC
- Status last verified
- Jul 2022
- First submitted
- 6 Dec 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6-week Probiotic Supplementation on Stress-related Parameters in Healthy Adults With Different Levels of Stress
- ClinicalTrials.gov ID
- NCT05226520
- Acronym / sponsor ID
- 2004NRC
- Conditions
- Mild to Moderate Levels of Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Exploratory, randomized, placebo-controlled, 2-arms, double-blinded, parallel
| Arm | Type | Receives |
|---|---|---|
| Probiotic NCC3001 | Experimental | Dietary Supplement: Experimental probiotic productSachets of NCC3001 and excipient (maltodextrin) to be administered orally every day for 6 weeks |
| Matched Placebo Comparator | Placebo comparator | Other: Placebo comparatorSachets of matching placebo containing maltodextrin, yeast extract, cystein HCl and pea flour to be administered orally every day for 6 weeks |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental probiotic productProbiotic supplementation | Dietary supplement | Probiotic NCC3001 |
| Placebo comparatorPlacebo | Other | Matched Placebo Comparator |
Primary outcome
Salivary cortisol level
Time frame: 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
13 secondary outcomes
Cortisol level from waking saliva samples
Time frame: Baseline and after 6 weeks treatment
Mean heart rate variability
Time frame: Baseline and after 6 weeks treatment
Heart frequency
Time frame: Baseline and after 6 weeks treatment
Mean skin conductance level
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (PANAS)
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before and after the stressor (STAI-6)
Time frame: Baseline and after 6 weeks treatment
Self-reported measures before, during and after the stressor (VAS)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (PSS)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (HADs)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (GSRS)
Time frame: Baseline and after 6 weeks treatment
Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)
Time frame: Baseline and after 6 weeks treatment
Probiotic in feces
Time frame: Baseline and after 6 weeks treatment
Microbiome related metabolites in stool, blood and urine
Time frame: Baseline and after 6 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Macé study director
Nestlé Institute of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental probiotic product in people with Mild to Moderate Levels of Stress, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol level (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.