Spread Bogatyr: 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

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT05543811

Collaborator

Group of companies EFKO (Other), Russian Science Foundation (Other)

140

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

25.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cognitive Change Memory; Disturbance, Mild Emotional Regulation Concentration Ability Impaired	Dietary Supplement: Food for special dietary use	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Product 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)	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
Placebo Comparator: control 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)	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

Arm

Intervention/Treatment

Experimental: Product 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)

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

Placebo Comparator: control

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)

Dietary Supplement: Food for special dietary use

Outcome Measures

Primary Outcome Measures

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

change in food's taste monotony [two weeks]
change in food's taste monotony

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

willingness to participate;
age of 18-50 years

Exclusion Criteria:

pregnancy or breastfeeding;
significant somatic or psychological disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow		Russian Federation	115446

Sponsors and Collaborators

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

Investigators

Study Chair: Vasily Isakov, Professor, Federal Research Center of Nutrition and Biotechnology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05543811

Other Study ID Numbers:

19-76-30014/2022-HV

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 19, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 19, 2022