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. (Tara)
Status
Completed
Conditions
Anxious Healthy Subjects
Treatments
Other: Milk product fermented by lactic bacteria or not fermented
Details and patient eligibility
About
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.
Enrollment
168 patients
Sex
Female
Ages
20 to 30 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
168 participants in 2 patient groups, including a placebo group
Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690
Active Comparator group
Treatment:
Other: Milk product fermented by lactic bacteria or not fermented
Arm 2, Control: Milk-based non-fermented dairy product
Placebo Comparator group
Treatment:
Other: Milk product fermented by lactic bacteria or not fermented
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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