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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
100
Catholic University of Murcia
Murcia, Spain
Cognitive performance
COMPASS cognitive test panel
Time frame: Change in baseline cognitive performance after 8 weeks of consumption
Perceived Stress Scale
PSS-14 test
Time frame: Day 1, at 4 and 8 weeks later
Mood profile
POMS test
Time frame: Day 1, at 4 and 8 weeks later
Depression, Anxiety and Stress
DASS21 test
Time frame: Day 1, at 4 and 8 weeks later
State of mind
PANAS test
Time frame: Day 1, at 4 and 8 weeks later
Stress status using VAS scale
Stress status on the day of the visit
Time frame: Day 1, at 4 and 8 weeks later
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: 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
Time frame: Day 1, at 4 and 8 weeks later
Gut microbiota
Evaluated with stool sample
Time frame: Day 1, at 4, 8 and 12 weeks later
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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.
Time frame: 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.
Time frame: Day 1, at 4, 8 and 12 weeks later
Dietary survey
Three days will be evaluated (two weekdays and one weekend day).
Time frame: Day 1, at 4, 8 and 12 weeks later
Body weight
Bioimpedance, in Kg. For this we will use a TANITA
Time frame: 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)
Time frame: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.