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| ID | Type | Description | Link |
|---|---|---|---|
| S64737 | Other Identifier | Ethische Commissie Onderzoek UZ/KU Leuven |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1, Test: Fermented milk product containing probiotics L. rhamnosus CNCM I-3690 | Active Comparator |
| |
| Arm 2, Control: Milk-based non-fermented dairy product | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk product fermented by lactic bacteria or not fermented | Other | 2 bottles of 100g consumed daily during 28 days |
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| Measure | Description | 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). |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
This study is reproducing a previous study with interesting results seen in women participants.
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| Name | Affiliation | Role |
|---|---|---|
| Rim HASSOUNA, PhD | DANONE RESEARCH, PALAISEAU, FRANCE | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ/KU Leuven | Leuven | 3000 | Belgium |
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A proof-of-efficacy, randomized, controlled, double-blind, monocentric, parallel arms design
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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.
| 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). |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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