Cognitive Change Clinical Trial
— ShotRMOfficial title:
Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Verified date | March 2022 |
Source | Universidad Católica San Antonio de Murcia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 25, 2023 |
Est. primary completion date | January 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Men and women aged 18-60 years. - Individuals with a diagnosis of mild-moderate stress according to the Cohen's perceived stress scale perceived stress scale (PSS-10). - Subjects with poor adherence to the Mediterranean diet according to the PREDIMED questionnaire (value below 9 points)*. - BMI between 19 and 30 kg/m2. Exclusion Criteria: - Present chronic and/or acute digestive pathologies that may interfere in the absorption of nutrients (inflammatory intestinal diseases, inflammatory bowel absorption of nutrients (inflammatory intestinal diseases, etc.), etc.) - Intake of probiotics and/or prebiotics in the four weeks prior to the inclusion in the study. - Individuals who are on antibiotic treatment or have completed an antibiotic treatment during the 30 days prior to inclusion in the study. - Vegan diet. - Being taking any type of supplementation that interacts with cognitive level in the 2 weeks prior to the start of the study. - Individuals who had taken or were taking any medications or supplementation for stress management, mood, or to induce sleep in the 2 weeks prior to the start of the study. - A history of allergic hypersensitivity or poor tolerance to any component of the products under study. - Consumption of 2 or more Standard Drink Units (UBE) daily or 17 weekly in women, or consume 4 or more UBE daily or 28 weekly in men. - Smoking and non-smoking subjects who have modified their nicotinic habits in the last 3 months. - Pregnant or lactating women. - Been participating or have participated in another clinical trial in the 2 months prior to the study to the study. - Unwillingness or inability to comply with the procedures of the clinical trial. - Subjects with any diagnosed psychiatric disorder. - Subjects whose condition makes them ineligible for the study in accordance with the criteria of the investigator. |
Country | Name | City | State |
---|---|---|---|
Spain | Catholic University of Murcia | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad Católica San Antonio de Murcia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive performance | COMPASS cognitive test panel | Change in baseline cognitive performance after 8 weeks of consumption | |
Secondary | Perceived Stress Scale | PSS-14 test | Day 1, at 4 and 8 weeks later | |
Secondary | Mood profile | POMS test | Day 1, at 4 and 8 weeks later | |
Secondary | Depression, Anxiety and Stress | DASS21 test | Day 1, at 4 and 8 weeks later | |
Secondary | State of mind | PANAS test | Day 1, at 4 and 8 weeks later | |
Secondary | Stress status using VAS scale | Stress status on the day of the visit | Day 1, at 4 and 8 weeks later | |
Secondary | 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). | |
Secondary | Sleep quality | Pittsburgh test | Day 1, at 4 and 8 weeks later | |
Secondary | Gut microbiota | Evaluated with stool sample | Day 1, at 4, 8 and 12 weeks later | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Dietary survey | Three days will be evaluated (two weekdays and one weekend day). | Day 1, at 4, 8 and 12 weeks later | |
Secondary | Body weight | Bioimpedance, in Kg. For this we will use a TANITA | Day 1, at 8 weeks later | |
Secondary | 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. |
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