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)

• ClinicalTrials.gov Identifier: NCT04780763
• Recruitment Status: Active, not recruiting
• First Posted: March 3, 2021
• Last Update Posted: December 13, 2021
• Sponsor: Danone Research
• Information provided by (Responsible Party): Danone Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxious Healthy Subjects	Other: Milk product fermented by lactic bacteria or not fermented	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

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.

• Primary Purpose: Supportive Care
• 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.
• Actual Study Start Date: March 4, 2021
• Actual Primary Completion Date: September 14, 2021
• Estimated Study Completion Date: December 22, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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. [ Time Frame: At Baseline and after stress challenge (4 weeks from baseline). ]
2. 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. [ Time Frame: At Baseline and at stress challenge (4 weeks from baseline). ]
3. Comparison between groups of Bond-Lader visual analogue scale (VAS) score during 4 weeks of investigational product consumption. [ Time Frame: At Baseline and at stress challenge (4 weeks from baseline). ]
4. Comparison between groups of cortisol levels in saliva after 4 weeks of investigational product consumption. [ Time Frame: Time course of cortisol secretion on the day of the stress challenge (5 timepoints). ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 30 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study is reproducing a previous study with interesting results seen in women participants.
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Belgium

UZ/KU Leuven

Leuven, Belgium, 3000

Sponsors and Collaborators

Danone Research

Investigators

• Study Chair: Rim HASSOUNA, PhD; DANONE RESEARCH, PALAISEAU, FRANCE

More Information

• Responsible Party: Danone Research
• ClinicalTrials.gov Identifier: NCT04780763
• Other Study ID Numbers: NU391; S64737 ( Other Identifier: Ethische Commissie Onderzoek UZ/KU Leuven )
• First Posted: March 3, 2021
• Last Update Posted: December 13, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Danone Research:

anxiety, academic stress, healthy women, fermented diary product, randomized controlled trial

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders