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

NCT05543811 | Completed DMC

• 1 other identifier: 19-76-30014/2022-HV
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

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

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 use DIETARY_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 use; control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pregnancy or breastfeeding;
• significant somatic or psychological disorders

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 115446, Russia

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Emotional Regulation

Interventions

Food

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vasily Isakov, Professor

  Federal Research Center of Nutrition and Biotechnology

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after study completion
• Access Criteria: reasonable request to primary investigator

Locations

RU (1)