Cognitive ChangeSpread BogatyrNCT05543811
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
A study testing Food for special dietary use in people with Cognitive Change and Memory; Disturbance, Mild, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Memory; Disturbance, Mild, Emotional Regulation
- What is being tested?
- Food for special dietary use
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willingness to participate;
- age of 18-50 years
Who cannot join
- pregnancy or breastfeeding;
- significant somatic or psychological disorders
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
About this study
Official title: 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
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
- Being tested
- Food for special dietary use
- Medical subject headings
- Lymphoma, Follicular, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Food for special dietary use |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognitive function
change in score by Lurie test
Measured: two weeks
change in cognitive function2
change in Kraepelin\&Schulte test score
Measured: two weeks
change in functional status
change in functional status test score
Measured: two weeks
change in anxiety and depression
change in Beck depression inventory score
Measured: two weeks
Secondary outcomes (1)
change in food's taste monotony
change in food's taste monotony
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start15 Sep 2022
- Primary completion31 Dec 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- EFKO Group, Russian Science Foundation
- Responsible party
- Sponsor
- Investigators
- Vasily Isakov, Professor, Study chair, Federal Research Center of Nutrition and Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543811
- Sponsor's protocol ID
- 19-76-30014/2022-HV
- Acronym
- Spread Bogatyr
- Status last verified
- Apr 2023
- First submitted
- 13 Sep 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Blinded individual participant data may be shared by reasonable request to primary investigator upon study completion
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05543811
- Acronym / sponsor ID
- Spread Bogatyr / 19-76-30014/2022-HV
- Conditions
- Cognitive Change, Memory; Disturbance, Mild, Emotional Regulation, Concentration Ability Impaired
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Collaborators
- EFKO Group, Russian Science Foundation
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product for special dietary use | Experimental | Dietary Supplement: Food for special dietary useSpread 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) |
| control | Placebo comparator | Dietary Supplement: Food for special dietary useThis group will receive standard spread, without theanine, gamma-aminobutyric acid and 5-hydroxytryptophan, twice daily with breakfast and supper with food (instead of butter) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- willingness to participate;
- age of 18-50 years
Key exclusion criteria (2 listed)
- pregnancy or breastfeeding;
- significant somatic or psychological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food for special dietary useFood 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 | Dietary supplement | Product for special dietary use, control |
Primary outcome
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
1 secondary outcome
change in food's taste monotony
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Yes. Blinded individual participant data may be shared by reasonable request to primary investigator upon study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasily Isakov, Professor study chair
Federal Research Center of Nutrition and Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food for special dietary use in people with Cognitive Change and Memory; Disturbance, Mild, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cognitive function (time frame: two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.