Skip to main content
MedPathMedPath Home
Clinical Trials/NCT05543811
NCT05543811
Completed
Not Applicable

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

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology1 site in 1 country140 target enrollmentSeptember 15, 2022
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCognitive ChangeMemory; Disturbance, MildEmotional RegulationConcentration Ability Impaired

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Change
Sponsor
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Enrollment
140
Locations
1
Primary Endpoint
change in cognitive function
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
September 15, 2022
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •pregnancy or breastfeeding;
  • •significant somatic or psychological disorders

Outcomes

Primary Outcomes

change in cognitive function

Time Frame: two weeks

change in score by Lurie test

change in cognitive function2

Time Frame: two weeks

change in Kraepelin\&Schulte test score

change in functional status

Time Frame: two weeks

change in functional status test score

change in anxiety and depression

Time Frame: two weeks

change in Beck depression inventory score

Secondary Outcomes

  • change in food's taste monotony(two weeks)

Study Sites (1)

Loading locations...

Similar Trials

Active, not recruiting
Not Applicable
Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (Ice Cream With Brazzein, Maltitol and Oligofructose; Ice Cream With Brazzein, Erythritol, Maltitol and Inulin) Compared to Standard (Sundae) Ice CreamNon-Alcoholic Steatohepatitis (NASH)Diabetes Mellitus Type 2 (T2DM)
NCT06724913Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology100
Recruiting
Not Applicable
Effect of an Amino Acids and Flavonoids Containing FSMP on Chemotherapy Toxicity, Nutritional Status and Quality of Life in Breast Cancer PatientsBreast Cancer
NCT05968677Flavolife Srl60
Completed
Phase 1
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female VolunteersContraception
NCT02852681Estetra28
Completed
Phase 1
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' PatientsChagas Disease
NCT02606864Bayer36
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics and Food Effects of Oral EC5026 in Healthy SubjectsHealthy Adults
NCT04908995EicOsis Human Health Inc.18