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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Morning Salivary Cortisol Level
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 17.0-29.9 kg/m²
- •Living in Moscow region
- •Provided informed consent
排除标准
- •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
研究组 & 干预措施
Functional Bar
Daily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks.
干预措施: Functional Bar (Dietary Supplement)
Placebo Bar
Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.
干预措施: Placebo Bar (Dietary Supplement)
结局指标
主要结局
Change in Morning Salivary Cortisol Level
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Igor Nikitin
Professor of the Department of Biotechnology of Food Products from Plant and Animal Raw Materials
K.G. Razumovsky Moscow State University of Technologies and Management