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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2021-12-22

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.

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Detailed Description

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Conditions

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Anxious Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study Test and Control products have been developed in order to guarantee the blinding, they will be similar by their taste, texture, color, packaging, nutritional content and flavor.

The blinding of study products will be performed by assigning a study product number corresponding to the randomization list. Then blinded study product packages will then be carried to the investigational site for assignment to the subject.

Product allocation will be performed by randomized method (IWRS validated system) as a Randomized Controlled Trial. The participants are thus assigned to intervention groups randomly.

Study Groups

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Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690

Group Type ACTIVE_COMPARATOR

Milk product fermented by lactic bacteria or not fermented

Intervention Type OTHER

2 bottles of 100g consumed daily during 28 days

Arm 2, Control: Milk-based non-fermented dairy product

Group Type PLACEBO_COMPARATOR

Milk product fermented by lactic bacteria or not fermented

Intervention Type OTHER

2 bottles of 100g consumed daily during 28 days

Interventions

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Milk product fermented by lactic bacteria or not fermented

2 bottles of 100g consumed daily during 28 days

Intervention Type OTHER

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes