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)

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.

Study Overview

• Status: Completed
• Conditions: Anxious Healthy Subjects
• Intervention / Treatment: Other: Milk product fermented by lactic bacteria or not fermented

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ/KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Danone Research
• Investigators: Study Chair: Rim HASSOUNA, PhD, Danone Research, Palaiseau, France

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): December 22, 2021

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: NU391; S64737 (Other Identifier: Ethische Commissie Onderzoek UZ/KU Leuven)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No