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The main objective of this project is to evaluate the absence of adverse gastrointestinal effects following the consumption of a daily probiotic capsule during 15 days.
The secondary objective of this study is to verify the absence of any adverse effects other than gastrointestinal ones following the daily consumption of a probiotic during 15 days in a healthy population.
Specific objectives are:
Target sample size is 20 subjects.
Participants will be allocated in one group (experimental group).
Participants will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 15).
Volunteers who wish to participate in the study will complete an online questionnaire to verify the main inclusion criteria. Those who meet the criteria will be invited to an information and screening visit to address any questions. Volunteers who agree to participate will sign the informed consent form.
During the intervention, participants will attend two clinical investigation visits. The first Clinical Investigation Day will be conducted on the same day as the screening, and the second Clinical Investigation Day will take place at the end of the 15-day period. In both visits, anthropometric measurements, gastrointestinal symptoms and a general questionnaire on adverse effects will be recorded. Volunteers will be required to consume one probiotic capsule per day during 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Capsule containing probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic group | Dietary Supplement | Daily consumption of one capsule containing a probiotic for 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Weight of participants will be measured by bioimpedance and reported in kg | Clinical Investigation Day 1 |
| Height | Height of participants will be measured by stadiometer and reported in m. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Aranaz, PhD | Contact | +34948425600 | 806390 | paranaz@unav.es |
| FermĂn Milagro, PhD | Contact | +34948425600 | 806553 | fmilagro@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Idoia Ibero, PhD | Center for Nutrition Research | Study Chair |
| Salomé Pérez | Center for Nutrition Research | Study Chair |
| Paula Aranaz, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Nutrition Research | Pamplona | Navarre | 31008 | Spain |
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| Clinical Investigation Day 1 |
| Body mass index | Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2 | Clinical Investigation Day 1 |
| Adherence to capsule consumption | Adherence will be assessed using the capsule consumption record form. | Clinical Investigation Day 2 |
| Headache | Headache will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Tiredness | Tiredness will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Muscle or joint pain | Muscle or joint pain will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Fever | Fever will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Chills | Chills will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Allergic reactions | Allergic reactions will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Difficulty sleeping | Difficulty sleeping will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Dizziness | Dizziness will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| General discomfort | General discomfort will be assess answering the General Questionnaire designed for the study. Answers could be None / Mild / Moderate / Severe. | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Mood | Mood will be assess answering the General Questionnaire designed for the study. Answers could be No / Yes, mild / Yes, moderate / Yes, severe | Clinical Investigation Day 2 |
| Other symptoms | Open question | Clinical Investigation Day 1 and Clinical Investigation Day 2 |
| Center for Nutrition Research |
| Principal Investigator |
| VerĂ³nica Ciaurriz | Center for Nutrition Research | Study Chair |
| Ana Lorente | Center for Nutrition Research | Study Chair |