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Single-center, randomized, double-blind, placebo-controlled clinical study with two study groups.
One group will consume a product with functional ingredients and the other group will consume a placebo product. will consume a placebo product.
When individuals are included in the study they will be randomized in equal proportion to one of the 2 groups of the study. The randomization will be stratified by age taking into account 2 strata (1:1). The first stratum corresponds to an age range of 18 to 40 years and the second stratum to an age range of 41 to 60 years.
The subject must consume the product for 8 weeks and will have a visit 4 weeks later as a follow-up of the study.
At the visits the subject will perform a series of cognitive tests and the intestinal microbiota will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The content of the package is 100 g and should be consumed once a day for 8 weeks. |
|
| Control group | Placebo Comparator | The content of the package is 100 g and should be consumed once a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Fermented milk product containing a probiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance | COMPASS cognitive test panel | Change in baseline cognitive performance after 8 weeks of consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | PSS-14 test | Day 1, at 4 and 8 weeks later |
| Mood profile | POMS test | Day 1, at 4 and 8 weeks later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fco Javier López Román | Catholic University of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | 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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| Placebo |
| Dietary Supplement |
Product with identical characteristics to the experimental product. |
|
| Depression, Anxiety and Stress | DASS21 test | Day 1, at 4 and 8 weeks later |
| State of mind | PANAS test | Day 1, at 4 and 8 weeks later |
| Stress status using VAS scale | Stress status on the day of the visit | Day 1, at 4 and 8 weeks later |
| Sleep efficiency | Measured by accelerometry, with Actigraph wGT3X-BT | It will be measured for 3 days, before starting the consumption of the product, after 30 days of consumption and at the end of consumption (60 days). |
| Sleep quality | Pittsburgh test | Day 1, at 4 and 8 weeks later |
| Gut microbiota | Evaluated with stool sample | Day 1, at 4, 8 and 12 weeks later |
| Adverse events | It will be evaluated at each of the visits and in the month of follow-up will be evaluated with a daily diary. | At 4 weeks, 8 and 12 weeks after consumption |
| Concomitant medication | The change in the use of medications will be evaluated. It will be evaluated at each of the visits and in the month of follow-up will be evaluated with a daily diary. | Day 1, at 4, 8 and 12 weeks later |
| Dietary survey | Three days will be evaluated (two weekdays and one weekend day). | Day 1, at 4, 8 and 12 weeks later |
| Body weight | Bioimpedance, in Kg. For this we will use a TANITA | Day 1, at 8 weeks later |
| Liver safety variables | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L) | It will be measured twice, once at baseline or at the end of the consumption after 8 weeks. |
| D019602 |
| Food and Beverages |