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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-04-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Group of companies EFKO

    collaborator UNKNOWN

  • Russian Science Foundation

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Vasily Isakov, Professor · Federal Research Center of Nutrition and Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2022-12-31
Completion
2023-02-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543811 on ClinicalTrials.gov