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

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

140

Conditions

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

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Moscow, Russia

Outcomes

Primary Outcomes

change in cognitive function

change in score by Lurie test

Time frame: two weeks

change in cognitive function2

change in Kraepelin\&Schulte test score

Time frame: two weeks

change in functional status

change in functional status test score

Time frame: two weeks

change in anxiety and depression

change in Beck depression inventory score

Time frame: two weeks

Secondary Outcomes

change in food's taste monotony

Time frame: two weeks

Data from ClinicalTrials.gov

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