Cognitive Change Clinical Trial
— Spread BogatyrOfficial title:
The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Disorders
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
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Group of companies EFKO, Russian Science Foundation |
Russian Federation,
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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