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The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention.
The main questions to answer are:
For this purpose, a randomized, double blind parallel study has been designed.
Target sample size is 60 subjects.
Participants will be allocated in two groups for 6 weeks:
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend two Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks. In both visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary, physical activity and catarrhal episodes will be taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Subjects will consume one capsule of probiotic, daily, during 6 weeks. |
|
| Placebo group | Placebo Comparator | Subjects will consume one capsule of placebo, daily, during 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic capsules |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota | Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary cortisol | Cortisol levels will be taken by Salivette®- Cortisol kit and analyzed by electrochemiluminescence immunoassay and reported in ug/dL. | Clinical Investigation Day 1 (at wake up in the morning) and Clinical Investigation Day 2 (at wake up in the morning, at the same time taken in the clinical investigation day 1)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FermÃn Milagro Yoldi, PhD | University of Navarra | Principal Investigator |
| Idoia Ibero-Baraibar, PhD | University of Navarra | Study Chair |
| Carlos González-Navarro | University of Navarra | Study Chair |
| Santiago Navas-Carretero | University of Navarra | Study Chair |
| Roncesvalles Garayoa, PhD | University of Navarra | Study Chair |
| Gabriela Arias | University of Navarra | Study Chair |
| Blanca Martinez | University of Navarra | Study Chair |
| Salomé Pérez | University of Navarra | Study Chair |
| MarÃa Goñi | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Nutrition Research | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomised, double blinded, parallel intervention
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The products (experimental and placebo), will be produced by an external producer, who will save the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
| Dietary Supplement |
Placebo capsules |
|
| Body weight |
Weight of participants will be measured by bioimpedance and reported in kg |
| Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Height | Height of participants will be measured by stadiometer and reported in m. | Clinical Investigation Day 1. |
| Body mass index | Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Body fat percentage | Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Body muscle mass | Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Body lean mass | Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Body water mass | Body water mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Body bone mass | Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| The incidence of catarrhal episodes | The number of catarrhal episodes will be registrated through a questionnaire designed for that purpose. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| The gravity of catarrhal episodes | The gravity (mild/half /serious) of catarrhal episodes will be registrated through a questionnaire designed for that purpose. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Gastrointestinal symptoms | Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Dietary intake | Dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Physical activity | Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire, which estimates the total physical activity in MET-min/week, time spent sitting and classifies subjects based on their physical activity | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| Adherence to capsule consumption | Adherence will be assessed using the capsule consumption record form. | Clinical Investigation Day 1 and Clinical Investigation Day 2. |
| D019602 |
| Food and Beverages |