Anxious Healthy Subjects Clinical Trial
— TaraOfficial 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.
| Verified date | March 2022 |
| Source | Danone Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 168 |
| Est. completion date | December 22, 2021 |
| Est. primary completion date | September 14, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 30 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ/KU Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Danone Research |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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). | ||
| Secondary | 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). | ||
| Secondary | 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). | ||
| Secondary | 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). |