Anxious Healthy SubjectsTaraNCT04780763
Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress.
A study testing Milk product fermented by lactic bacteria or not fermented in people with Anxious Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the effect of Lactobacillus rhamnosus CNCM I-3690 consumption on subjective anxiety levels in healthy subjects undergoing academic stress. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxious Healthy Subjects
- What is being tested?
- Milk product fermented by lactic bacteria or not fermented
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Mar 2021to 22 Dec 2021
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- SI01: Free-living Participant who fully understands and agree to the objectives of the study, who gave signed and dated informed consent
- SI02: Women of 20 to 30 years of age inclusive
- SI03: Participants who are healthy as determined by medical evaluation including medical and surgical history and full physical examination.
- SI04: Body mass index (BMI) within the range 18 and 30 kg/m2 (bounds included).
- SI05: Woman participants.
- SI06: Student defending a bachelor's or master's thesis in front of a jury
- SI07: Subject who regularly consumes dairy fermented products containing live bacteria and willing to consume 2 units of investigational product per day during the study.
- SI08: Subject willing to strictly follow instructions on diet, medication and substance use for the entire duration of the study.
Who cannot join
- SE01: subject with chronic gastrointestinal disorders or symptoms, with celiac disease, diagnosed type 1 or type 2 diabetes mellitus, with psychiatric disease including but not limited to depression and general anxiety disorder
- SE03: subject with food allergy, history of atopic conditions (eczema, allergic asthma, allergic rhino conjunctivitis) requiring active treatment, with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes, with known or suspected lactose intolerance
- SE4: Subject with eating disorders, chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV), presenting a severe evolutive or chronic pathology (e.g. cancer, tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis)
- SE5: Subject with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever and/or with a positive test for COVID-19 infection or presenting any symptoms of COVID infection in the past 2 weeks
- SE6: Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, and steroids prescribed in chronic inflammatory diseases, antiphlogistic, anti-inflammatory and PPIs)
- SE7: Subject who has planned to participate in another investigational study OR subject involved in any other clinical study within the preceding month
- SE8: Subjects planning to significantly change their diet during the period of the study or who have changed his/her dietary habits within the 4 weeks preceding the study (e.g. start of a diet high in fibres)
- SE9: Pregnant woman or woman planning to become pregnant during the study; breast-feeding woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress. A Proof-of-efficacy, Randomized, Controlled, Double-blind, Monocentric, Parallel Arms Design Study.
The purpose of this study is to assess the effect of Lactobacillus rhamnosus CNCM I-3690 consumption on subjective anxiety levels in healthy subjects undergoing academic stress.
- Conditions
- Anxious Healthy Subjects
- Being tested
- Milk product fermented by lactic bacteria or not fermented
- Keywords
- anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk product fermented by lactic bacteria or not fermentedOther
2 bottles of 100g consumed daily during 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690 | Active comparator | Not described Receives: Other: Milk product fermented by lactic bacteria or not fermented |
| Arm 2, Control: Milk-based non-fermented dairy product | Placebo comparator | Not described Receives: Other: Milk product fermented by lactic bacteria or not fermented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between groups of the State-Trait Anxiety Inventory (STAI)-state questionnaire score during 4 weeks of investigational product consumption.
Measured: At Baseline and after stress challenge (4 weeks after baseline).
Secondary outcomes (4)
Comparison between groups of cortisol level in saliva, Perceived Stress Scale (PSS) questionnaire score and Heart Rate Variability (HRV) during 4 weeks of investigational product consumption.
Measured: At Baseline and after stress challenge (4 weeks from baseline).
Comparison between groups of sleep efficiency, total sleep time, and deep sleep (Non-REM 3 sleep cycle) duration, during 4 weeks of investigational product consumption.
Measured: At Baseline and at stress challenge (4 weeks from baseline).
Comparison between groups of Bond-Lader visual analogue scale (VAS) score during 4 weeks of investigational product consumption.
Measured: At Baseline and at stress challenge (4 weeks from baseline).
Comparison between groups of cortisol levels in saliva after 4 weeks of investigational product consumption.
Measured: Time course of cortisol secretion on the day of the stress challenge (5 timepoints).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start4 Mar 2021
- Primary completion14 Sep 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxious Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rim HASSOUNA, PhD, Study chair, DANONE RESEARCH, PALAISEAU, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780763
- Sponsor's protocol ID
- NU391
- Other IDs
- S64737
- Acronym
- Tara
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress. A Proof-of-efficacy, Randomized, Controlled, Double-blind, Monocentric, Parallel Arms Design Study.
- ClinicalTrials.gov ID
- NCT04780763
- Acronym / sponsor ID
- Tara / NU391
- Conditions
- Anxious Healthy Subjects
- Keywords
- anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 3 Mar 2021 (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.
The purpose of this study is to assess the effect of Lactobacillus rhamnosus CNCM I-3690 consumption on subjective anxiety levels in healthy subjects undergoing academic stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690 | Active comparator | Other: Milk product fermented by lactic bacteria or not fermented |
| Arm 2, Control: Milk-based non-fermented dairy product | Placebo comparator | Other: Milk product fermented by lactic bacteria or not fermented |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- SI01: Free-living Participant who fully understands and agree to the objectives of the study, who gave signed and dated informed consent
- SI02: Women of 20 to 30 years of age inclusive
- SI03: Participants who are healthy as determined by medical evaluation including medical and surgical history and full physical examination.
- SI04: Body mass index (BMI) within the range 18 and 30 kg/m2 (bounds included).
- SI05: Woman participants.
Key exclusion criteria (8 listed)
- SE01: subject with chronic gastrointestinal disorders or symptoms, with celiac disease, diagnosed type 1 or type 2 diabetes mellitus, with psychiatric disease including but not limited to depression and general anxiety disorder
- SE03: subject with food allergy, history of atopic conditions (eczema, allergic asthma, allergic rhino conjunctivitis) requiring active treatment, with first degree relatives with coeliac disease, inflammatory bowel disease (IBD) or type 1 diabetes, with known or suspected lactose intolerance
- SE4: Subject with eating disorders, chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV), presenting a severe evolutive or chronic pathology (e.g. cancer, tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis)
- SE5: Subject with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever and/or with a positive test for COVID-19 infection or presenting any symptoms of COVID infection in the past 2 weeks
- SE6: Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (antibiotics, intestinal or respiratory antiseptics, anti-rheumatics, and steroids prescribed in chronic inflammatory diseases, antiphlogistic, anti-inflammatory and PPIs)
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 |
|---|---|---|
| Milk product fermented by lactic bacteria or not fermented2 bottles of 100g consumed daily during 28 days | Other | Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690, Arm 2, Control: Milk-based non-fermented dairy product |
Primary outcome
Comparison between groups of the State-Trait Anxiety Inventory (STAI)-state questionnaire score during 4 weeks of investigational product consumption.
Time frame: At Baseline and after stress challenge (4 weeks after baseline).
4 secondary outcomes
Comparison between groups of cortisol level in saliva, Perceived Stress Scale (PSS) questionnaire score and Heart Rate Variability (HRV) during 4 weeks of investigational product consumption.
Time frame: At Baseline and after stress challenge (4 weeks from baseline).
Comparison between groups of sleep efficiency, total sleep time, and deep sleep (Non-REM 3 sleep cycle) duration, during 4 weeks of investigational product consumption.
Time frame: At Baseline and at stress challenge (4 weeks from baseline).
Comparison between groups of Bond-Lader visual analogue scale (VAS) score during 4 weeks of investigational product consumption.
Time frame: At Baseline and at stress challenge (4 weeks from baseline).
Comparison between groups of cortisol levels in saliva after 4 weeks of investigational product consumption.
Time frame: Time course of cortisol secretion on the day of the stress challenge (5 timepoints).
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 23 Mar 2022.
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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.
Rim HASSOUNA, PhD study chair
DANONE RESEARCH, PALAISEAU, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk product fermented by lactic bacteria or not fermented in people with Anxious Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in Belgium.
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 8 inclusion and 8 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 23 Mar 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 Belgium. 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?
Comparison between groups of the State-Trait Anxiety Inventory (STAI)-state questionnaire score during 4 weeks of investigational product consumption. (time frame: At Baseline and after stress challenge (4 weeks after baseline).). 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 23 Mar 2022.