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

Not Applicable

Completed

• Conditions: Cognitive Change; Memory; Disturbance, Mild; Emotional Regulation; Concentration Ability Impaired
• Interventions: Dietary Supplement: Food for special dietary use

• Registration Number: NCT05543811
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study Start: 2022-09-15
• Study First Posted: 2022-09-16
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

• pregnancy or breastfeeding;
• significant somatic or psychological disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Product for special dietary use	Food for special dietary use	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	Food for special dietary use	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in food's taste monotony	two weeks	change in food's taste monotony

Trial Locations

Locations (1)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology; 🇷🇺 Moscow, Russian Federation