Catholic University of Murcia
Murcia, 30107, Spain
NCT Number: NCT05323825
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Murcia, 30107, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fermented milk product containing a probiotic
Product with identical characteristics to the experimental product.
Time frame: Change in baseline cognitive performance after 8 weeks of consumption
COMPASS cognitive test panel
Time frame: Day 1, at 4 and 8 weeks later
PSS-14 test
Time frame: Day 1, at 4 and 8 weeks later
POMS test
Time frame: Day 1, at 4 and 8 weeks later
DASS21 test
Time frame: Day 1, at 4 and 8 weeks later
PANAS test
Time frame: Day 1, at 4 and 8 weeks later
Stress status on the day of the visit
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).
Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: Day 1, at 4 and 8 weeks later
Pittsburgh test
Time frame: Day 1, at 4, 8 and 12 weeks later
Evaluated with stool sample
Time frame: At 4 weeks, 8 and 12 weeks after consumption
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
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
Three days will be evaluated (two weekdays and one weekend day).
Time frame: Day 1, at 8 weeks later
Bioimpedance, in Kg. For this we will use a TANITA
Time frame: It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.
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)
Universidad Católica San Antonio de Murcia
Other
Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance
Acronym: ShotRM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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