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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)

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ClinicalTrials.gov Identifier: NCT04780763
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Danone Research

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : March 4, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




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). ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780763


Contacts
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Contact: Silvia MIRET-CATALAN +33 (0)6 15 37 21 02 silvia.miret-catalan@danone.com
Contact: Jennifer LOURENCO +33 (0)6 29 22 03 68 Jennifer.lourenco@danone.com

Locations
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Belgium
UZ/KU Leuven
Leuven, Belgium, 3000
Contact: Karlien Geboers    +32 16 34 52 82    karlien.geboers@uzleuven.be   
Principal Investigator: Tim Vanuytsel, MD Prof.         
Sponsors and Collaborators
Danone Research
Investigators
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Study Chair: Rim HASSOUNA, PhD DANONE RESEARCH, PALAISEAU, FRANCE
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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    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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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:
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Anxiety Disorders
Mental Disorders