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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05543811

Acronym

Spread Bogatyr

Enrollment

140

Registered

2022-09-16

Start date

2022-09-15

Completion date

2023-02-28

Last updated

2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DIETARY_SUPPLEMENTFood for special dietary use

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* pregnancy or breastfeeding; * significant somatic or psychological disorders

Design outcomes

Primary

Measure	Time frame	Description
change in cognitive function	two weeks	change in score by Lurie test
change in cognitive function2	two weeks	change in Kraepelin&Schulte test score
change in functional status	two weeks	change in functional status test score
change in anxiety and depression	two weeks	change in Beck depression inventory score

Secondary

Measure	Time frame	Description
change in food's taste monotony	two weeks	change in food's taste monotony

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026