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The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men.
The main questions to answer are:
For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 30 subjects.
Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product).
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 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule |
|
| Group 2 | Active Comparator | 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota | Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology. | Clinical Investigation Days 1, 2, 3 and 4. |
| 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 Days 1, 2, 3 and 4 (at wake up in the morning, and at the same time in each Clinical investigation days). |
| Body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FermÃn I Milagro Yoldi, PhD | University of Navarra | Principal Investigator |
| Idoia Ibero-Baraibar, PhD | University of Navarra | Study Chair |
| Carlos González-Navarro, PhD | University of Navarra | Study Chair |
| Santiago Navas-Carretero, PhD | University of Navarra | Study Chair |
| Gabriela Arias | University of Navarra | Study Chair |
| Roncesvalles Garayoa, PhD | University of Navarra | Study Chair |
| MarÃa Goñi | University of Navarra | Study Chair |
| Salomé Pérez | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Nutrition Research | Pamplona | Navarre | Spain |
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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, crossover 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.
| Placebo |
| Dietary Supplement |
Placebo capsules |
|
Weight of participants will be measured by bioimpedance and reported in kg |
| Clinical Investigation Days 1, 2, 3 and 4 |
| 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 (kg)/ height (cm)2. | Clinical Investigation Days 1, 2, 3 and 4 |
| Body fat percentage | Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms. | Clinical Investigation Days 1, 2, 3 and 4 |
| Body muscle mass | Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Days 1, 2, 3 and 4 |
| Body lean mass | Body lean mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Days 1, 2, 3 and 4 |
| Body water mass | Body water mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Days 1, 2, 3 and 4 |
| Body bone mass | Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms. | Clinical Investigation Days 1, 2, 3 and 4 |
| Gastrointestinal symptoms | Gastrointestinal symptoms will be registrated through 15 items likert questionnaire; gastrointestinal symptoms rating scale questionnaire. | Clinical Investigation Days 1, 2, 3 and 4 |
| Dietary intake | Dietary intake will be analysed by food frequency questionnaire. | Clinical Investigation Days 1, 2, 3 and 4 |
| Physical activity | Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire (IPAQ). | Clinical Investigation Days 1, 2, 3 and 4 |
| Adherence to capsule consumption | Adherence will be assessed using the capsule consumption record form. | Clinical Investigation Days 1, 2, 3 and 4 |
| D019602 |
| Food and Beverages |