Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (4)

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 Outcomes (1)

change in food's taste monotony
two weeks

Study Arms (2)

Product for special dietary use

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Interventions

Food for special dietary useDietary supplement

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

Product for special dietary usecontrol

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

willingness to participate;
age of 18-50 years

You may not qualify if:

Sponsors & Collaborators

Russian Science Foundation
Othercollaborator
EFKO Group
Industrycollaborator
Federal State Budgetary Scientific Institution

Study Sites (1)

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

Moscow, 115446, Russia

MeSH Terms

Conditions

Lymphoma, FollicularEmotional Regulation

Interventions

Food

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesSelf-ControlSocial Behavior

Study Officials

Vasily Isakov, Professor
Federal Research Center of Nutrition and Biotechnology
STUDY CHAIR

Enrollment

140 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 15, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (2)

Product for special dietary use

control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (2)

Product for special dietary use

control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations