StressNCT07585422
Effect of Magnesium-, Vitamin C- and Grape Seed Extract-Enriched Date Bars on Perceived Stress and Salivary Cortisol Levels in Young Women
A study testing Functional Bar in people with Stress and Stress (Psychology), run by K.G. Razumovsky Moscow State University of Technologies and Management at 1 site in Russia.
Trial summary
This randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress (Psychology)
- What is being tested?
- Functional Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 22 May 2026to 4 Jul 2026
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 17.0-29.9 kg/m²
- Living in Moscow region
- Provided informed consent
Who cannot join
- Diagnosed psychiatric disorders
- Use of glucocorticoids or hormonal medications
- Use of dietary supplements containing magnesium, vitamin C, or polyphenols
- Chronic endocrine disorders
- Baseline salivary cortisol <1.5 ng/mL
- Allergy to bar components
Trial locations and contacts
1 site in 1 country.
Russia1 site
K.G. Razumovsky Moscow State University of Technologies and Management
Moscow, 109004
About this study
Official title: A Randomized Controlled Trial Evaluating the Effects of Functional Date Bars Enriched With Magnesium, Vitamin C, and Grape Seed Extract on Perceived Stress and Salivary Cortisol in Healthy Young Women
This randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Participants will be randomly assigned to either an intervention group receiving the enriched bar or a control group receiving a placebo bar identical in appearance and taste. Primary outcomes include changes in salivary cortisol levels and perceived stress (PSS-14).
Read the detailed description
Chronic psychological stress is a risk factor for depression, anxiety, eating disorders, and various metabolic disorders. Dietary components, including magnesium, vitamin C, and polyphenols (grape seed extract), have the potential to modulate the stress response through their effects on the hypothalamic-pituitary-adrenal (HPA) axis and the antioxidant status of consumers. However, data on the effects of complex nutritional interventions in healthy young women are limited: most studies have focused on the use of dietary supplements in their pure form, without their inclusion in food matrices. At the same time, the use of complete, multi-component functional foods offers advantages in the form of an improved consumer experience (a date bar has more appealing organoleptic characteristics compared to vitamin and mineral premixes and tablets, and consumption of the bar does not require additional preparation, such as dissolution in water). The development and study of the clinical properties of functional foods is relevant for the emerging personalized nutrition market.
This study investigates the effects of a functional food product (date-based bar enriched with magnesium, vitamin C, and grape seed extract) compared to a placebo bar over a 4-week period in healthy women aged 18-28 years.
- Conditions
- Stress, Stress (Psychology)
- Being tested
- Functional Bar, Placebo Bar
- Keywords
- magnesium, vitamin C, grape seed extract, salivary cortisol, perceived stress, nutrition intervention, functional food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional BarDietary supplement
Daily consumption of a functional date-based bar enriched with magnesium (240 mg), vitamin C (300 mg), and grape seed extract (100 mg) for 4 weeks.
Placebo BarDietary supplement
Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional Bar | Experimental | Daily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks. Receives: Dietary Supplement: Functional Bar |
| Placebo Bar | Placebo comparator | Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks. Receives: Dietary Supplement: Placebo Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Morning Salivary Cortisol Level
Salivary cortisol levels are measured in the morning (6:00-10:00 AM), 30-60 minutes after waking, to capture the morning peak. Cortisol concentrations are reported in ng/mL. The typical reference range for morning salivary cortisol levels in healthy adults is approximately 1.0-7.1 ng/mL, although absolute values may vary depending on the assay used.
The primary analysis is based on the change in cortisol levels within a subject from baseline to 4 weeks. A decrease in morning salivary cortisol levels is generally interpreted as a reduction in the physiological stress response (a positive result in the context of stress reduction). An increase may indicate an increase in the stress response. Both directions are analyzed as continuous changes, and differences between groups in change scores will be compared.
Measured: Baseline and 4 weeks
Change in Perceived Stress Scale (PSS-14) score
The Perceived Stress Scale (PSS-14) is a 14-item self-reported questionnaire measuring the degree to which situations in one's life are appraised as stressful. Each item is scored from 0 (Never) to 4 (Very often). Total scores range from 0 to 56, with higher scores indicating higher perceived stress. In this study, the absolute score is not used as a threshold; rather, improvement is defined as a reduction (decrease) in the PSS-14 score from baseline to follow-up. Any decrease reflects a positive outcome (reduction in perceived stress), regardless of the final score.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start22 May 2026
- Primary completion2 Jul 2026
- Study completion4 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- K.G. Razumovsky Moscow State University of Technologies and Management
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Nikitin, K.G. Razumovsky Moscow State University of Technologies and Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585422
- Sponsor's protocol ID
- MSUTM_001
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effects of Functional Date Bars Enriched With Magnesium, Vitamin C, and Grape Seed Extract on Perceived Stress and Salivary Cortisol in Healthy Young Women
- ClinicalTrials.gov ID
- NCT07585422
- Acronym / sponsor ID
- MSUTM_001
- Conditions
- Stress, Stress (Psychology)
- Keywords
- magnesium, vitamin C, grape seed extract, salivary cortisol, perceived stress, nutrition intervention, functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- K.G. Razumovsky Moscow State University of Technologies and ManagementUniversity, hospital or other
- Study start
- 22 May 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 4 Jul 2026 (actual)
- First posted
- 13 May 2026 (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 randomized controlled trial aims to evaluate the effect of a 4-week daily consumption of a functional date bar enriched with magnesium, vitamin C, and grape seed extract on perceived stress and salivary cortisol levels in healthy young women. Participants will be randomly assigned to either an intervention group receiving the enriched bar or a control group receiving a placebo bar identical in appearance and taste. Primary outcomes include changes in salivary cortisol levels and perceived stress (PSS-14).
Detailed description
Chronic psychological stress is a risk factor for depression, anxiety, eating disorders, and various metabolic disorders. Dietary components, including magnesium, vitamin C, and polyphenols (grape seed extract), have the potential to modulate the stress response through their effects on the hypothalamic-pituitary-adrenal (HPA) axis and the antioxidant status of consumers. However, data on the effects of complex nutritional interventions in healthy young women are limited: most studies have focused on the use of dietary supplements in their pure form, without their inclusion in food matrices. At the same time, the use of complete, multi-component functional foods offers advantages in the form of an improved consumer experience (a date bar has more appealing organoleptic characteristics compared to vitamin and mineral premixes and tablets, and consumption of the bar does not require additional preparation, such as dissolution in water). The development and study of the clinical properties of functional foods is relevant for the emerging personalized nutrition market.
This study investigates the effects of a functional food product (date-based bar enriched with magnesium, vitamin C, and grape seed extract) compared to a placebo bar over a 4-week period in healthy women aged 18-28 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Bar | Experimental | Dietary Supplement: Functional BarDaily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks. |
| Placebo Bar | Placebo comparator | Dietary Supplement: Placebo BarDaily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 17.0-29.9 kg/m²
- Living in Moscow region
- Provided informed consent
Key exclusion criteria (6 listed)
- Diagnosed psychiatric disorders
- Use of glucocorticoids or hormonal medications
- Use of dietary supplements containing magnesium, vitamin C, or polyphenols
- Chronic endocrine disorders
- Baseline salivary cortisol <1.5 ng/mL
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 |
|---|---|---|
| Functional BarDaily consumption of a functional date-based bar enriched with magnesium (240 mg), vitamin C (300 mg), and grape seed extract (100 mg) for 4 weeks. | Dietary supplement | Functional Bar |
| Placebo BarDaily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks. | Dietary supplement | Placebo Bar |
Primary outcome
Change in Morning Salivary Cortisol Level
Time frame: Baseline and 4 weeks
Salivary cortisol levels are measured in the morning (6:00-10:00 AM), 30-60 minutes after waking, to capture the morning peak. Cortisol concentrations are reported in ng/mL. The typical reference range for morning salivary cortisol levels in healthy adults is approximately 1.0-7.1 ng/mL, although absolute values may vary depending on the assay used. The primary analysis is based on the change in cortisol levels within a subject from baseline to 4 weeks. A decrease in morning salivary cortisol levels is generally interpreted as a reduction in the physiological stress response (a positive result in the context of stress reduction). An increase may indicate an increase in the stress response. Both directions are analyzed as continuous changes, and differences between groups in change scores will be compared.
Change in Perceived Stress Scale (PSS-14) score
Time frame: Baseline and 4 weeks
The Perceived Stress Scale (PSS-14) is a 14-item self-reported questionnaire measuring the degree to which situations in one's life are appraised as stressful. Each item is scored from 0 (Never) to 4 (Very often). Total scores range from 0 to 56, with higher scores indicating higher perceived stress. In this study, the absolute score is not used as a threshold; rather, improvement is defined as a reduction (decrease) in the PSS-14 score from baseline to follow-up. Any decrease reflects a positive outcome (reduction in perceived stress), regardless of the final score.
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Bar in people with Stress and Stress (Psychology), run by K.G. Razumovsky Moscow State University of Technologies and Management 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 3 inclusion and 6 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 9 Jul 2026. 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 Morning Salivary Cortisol Level (time frame: Baseline and 4 weeks). The study lists 2 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 9 Jul 2026.