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Completed

NCT Number: NCT05543811

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

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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Key information

Conditions

Cognitive Change Behavior Concentration Ability Impaired Emotional Regulation Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Memory; Disturbance, Mild Neoplasms Neoplasms by Histologic Type Self-Control Social Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, 115446, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • willingness to participate;
  • age of 18-50 years

Exclusion criteria

  • pregnancy or breastfeeding;
  • significant somatic or psychological disorders

Treatment and study plan

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

Primary outcomes

  1. change in cognitive function

    Time frame: two weeks

    change in score by Lurie test

  2. change in cognitive function2

    Time frame: two weeks

    change in Kraepelin&Schulte test score

  3. change in functional status

    Time frame: two weeks

    change in functional status test score

  4. change in anxiety and depression

    Time frame: two weeks

    change in Beck depression inventory score

Secondary outcomes

  1. change in food's taste monotony

    Time frame: two weeks

    change in food's taste monotony

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Scientific Institution

Other Gov

Collaborators

  • Group of companies EFKO
  • Russian Science Foundation

Registry information

Official study 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

Acronym: Spread Bogatyr

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 16, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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