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 Pathology

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cognitive Change, Memory; Disturbance, Mild, Emotional Regulation, Concentration Ability Impaired

Intervention / Treatment
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* Dietary Supplement: Food for special dietary use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willingness to participate; age of 18-50 years Exclusion Criteria: pregnancy or breastfeeding; significant somatic or psychological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product for special dietary use<br>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) | Dietary Supplement: Food for special dietary use<br>* 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<br>|
| Placebo Comparator: control<br>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) | Dietary Supplement: Food for special dietary use<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in food's taste monotony | change in food's taste monotony | two weeks |