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| Name | Class |
|---|---|
| Group of companies EFKO | UNKNOWN |
| Russian Science Foundation | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product for special dietary use | Experimental | Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid will be given to the subjects enrolled to this arm, 20 gram twice daily with breakfast and supper (instead of butter) |
|
| control | Placebo Comparator | This group will receive standard spread, without theanine, gamma-aminobutyric acid and 5-hydroxytryptophan, twice daily with breakfast and supper with food (instead of butter) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food for special dietary use | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in cognitive function | change in score by Lurie test | two weeks |
| change in cognitive function2 | change in Kraepelin&Schulte test score | two weeks |
| change in functional status | change in functional status test score | two weeks |
| change in anxiety and depression | change in Beck depression inventory score | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in food's taste monotony | change in food's taste monotony | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vasily Isakov, Professor | Federal Research Center of Nutrition and Biotechnology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Moscow | 115446 | Russia |
Blinded individual participant data may be shared by reasonable request to primary investigator upon study completion
2 years after study completion
reasonable request to primary investigator
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|
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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