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 (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 Disorders

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

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Emotional Regulation; Concentration Ability Impaired; Memory; Disturbance, Mild
• Intervention / Treatment: Dietary supplement: Food for special dietary use

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergey Morozov, MD, PhD; Phone Number: 0074996131091; Email: 84996131091@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy or breastfeeding;
• significant somatic or psychological disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Collaborators: Russian Science Foundation; Group of companies EFKO
• Investigators: Study Chair: Vasily Isakov, Professor, Federal Research Center of Nutrition and Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-76-30014/2022-HV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Blinded individual participant data may be shared by reasonable request to primary investigator upon study completion
• IPD Sharing Time Frame: 2 years after study completion
• IPD Sharing Access Criteria: reasonable request to primary investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No