Effect of Magnesium-, Vitamin C- and Grape Seed Extract-Enriched Date Bars on Perceived Stress and Salivary Cortisol Levels in Young Women

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).

Study Overview

• Status: Recruiting
• Conditions: Stress; Stress (Psychology)
• Intervention / Treatment: Dietary supplement: Functional Bar; Dietary supplement: Placebo Bar

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Igor A. Nikitin, Doctor of Technical Sciences; Phone Number: 1097 +7(495)8001200; Email: i.nikitin@mgutm.ru

Study Locations

• Russia
  • Moscow, Russia, 109004
    • Recruiting
    • K.G. Razumovsky Moscow State University of Technologies and Management
    • Contact: Igor A. Nikitin, Doctor of Technical Sciences; Phone Number: 1097 +7(495)8001200; Email: i.nikitin@mgutm.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Bar; Daily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks.	Dietary supplement: Functional 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.
Placebo Comparator: Placebo Bar; Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.	Dietary supplement: Placebo Bar; Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: K.G. Razumovsky Moscow State University of Technologies and Management

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 5, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: magnesium; salivary cortisol; vitamin C; nutrition intervention; functional food; perceived stress; grape seed extract
• Other Study ID Numbers: MSUTM_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No