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)

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

Status: Completed

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

Treatments: Dietary Supplement: Food for special dietary use

Study type: Interventional

Funder types: Other

Identifiers

NCT05543811

19-76-30014/2022-HV

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy or breastfeeding;
• significant somatic or psychological disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Product for special dietary use

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Food for special dietary use

control

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Food for special dietary use