Stress, Stress (Psychology)
Conditions
Keywords
magnesium, vitamin C, grape seed extract, salivary cortisol, perceived stress, nutrition intervention, functional food
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTFunctional Bar
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.
DIETARY_SUPPLEMENTPlacebo Bar
Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.
Sponsors
K.G. Razumovsky Moscow State University of Technologies and Management
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 17.0-29.9 kg/m² * Living in Moscow region * Provided informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Morning Salivary Cortisol Level | 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 | 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. |
Countries
Russia
Outcome results
None listed