Clinical trial NCT04780763: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxious Healthy Subjects
Keywords: anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 168
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between groups of the State-Trait Anxiety Inventory (STAI)-state questionnaire score during 4 weeks of investigational product consumption.
timeFrame: At Baseline and after stress challenge (4 weeks after baseline).
Secondary outcomes:
measure: 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.
timeFrame: At Baseline and after stress challenge (4 weeks from baseline).
measure: 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.
timeFrame: At Baseline and at stress challenge (4 weeks from baseline).
measure: Comparison between groups of Bond-Lader visual analogue scale (VAS) score during 4 weeks of investigational product consumption.
timeFrame: At Baseline and at stress challenge (4 weeks from baseline).
measure: Comparison between groups of cortisol levels in saliva after 4 weeks of investigational product consumption.
timeFrame: Time course of cortisol secretion on the day of the stress challenge (5 timepoints).
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ/KU Leuven
Study officials:
affiliation: DANONE RESEARCH, PALAISEAU, FRANCE
name: Rim HASSOUNA, PhD
role: STUDY_CHAIR
References: