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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05543811
Other study ID # 19-76-30014/2022-HV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date February 28, 2023

Study information

Verified date April 2023
Source Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-centre, single-blind, two-arms, controlled study to assess the efficacy and safety of food for special dietary use enriched with 5-hydroxytryptophan, L-theanine and Gamma-aminobutyric acid in generally healthy subjects with no cognitive disturbances


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date February 28, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - willingness to participate; - age of 18-50 years Exclusion Criteria: - pregnancy or breastfeeding; - significant somatic or psychological disorders

Study Design


Intervention

Dietary Supplement:
Food for special dietary use
Food for special dietary use (spread) with modified ingredients' content will be included to the diet of 70 patients without significant organic pathology for 14 days receiving standard diet, modified by the inclusion of two portions of the spread, 20 grams each for breakfast and dinner

Locations

Country Name City State
Russian Federation Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology Moscow

Sponsors (3)

Lead Sponsor Collaborator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology Group of companies EFKO, Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in cognitive function change in score by Lurie test two weeks
Primary change in cognitive function2 change in Kraepelin&Schulte test score two weeks
Primary change in functional status change in functional status test score two weeks
Primary change in anxiety and depression change in Beck depression inventory score two weeks
Secondary change in food's taste monotony change in food's taste monotony two weeks
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