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

Cognitive Change Clinical Trial

— Spread Bogatyr  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05543811
• Other study ID #: 19-76-30014/2022-HV
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy or breastfeeding;
• significant somatic or psychological disorders

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Food 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

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Group of companies EFKO, Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cognitive function	change in score by Lurie test	two weeks
Primary	change in cognitive function2	change in Kraepelin&Schulte test score	two weeks
Primary	change in functional status	change in functional status test score	two weeks
Primary	change in anxiety and depression	change in Beck depression inventory score	two weeks
Secondary	change in food's taste monotony	change in food's taste monotony	two weeks