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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Anxious Healthy Subjects

Intervention / Treatment
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* Other: Milk product fermented by lactic bacteria or not fermented


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690<br> | Other: Milk product fermented by lactic bacteria or not fermented<br>* 2 bottles of 100g consumed daily during 28 days<br>|
| Placebo Comparator: Arm 2, Control: Milk-based non-fermented dairy product<br> | Other: Milk product fermented by lactic bacteria or not fermented<br>* 2 bottles of 100g consumed daily during 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between groups of the State-Trait Anxiety Inventory (STAI)-state questionnaire score during 4 weeks of investigational product consumption. |  | At Baseline and after stress challenge (4 weeks after baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | 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. |  | 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 course of cortisol secretion on the day of the stress challenge (5 timepoints). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial