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

NCT07585422 | Not Yet Recruiting

• 1 other identifier: MSUTM_001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress; Stress (Psychology)

Keywords

magnesium; vitamin C; grape seed extract; salivary cortisol; perceived stress; nutrition intervention; functional food

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Functional Bar

EXPERIMENTAL

Daily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks.

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.

Dietary Supplement: Placebo Bar

Interventions

Functional Bar DIETARY_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.

Functional Bar

Placebo Bar DIETARY_SUPPLEMENT

Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.

Placebo Bar

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 17.0-29.9 kg/m²
• Living in Moscow region
• Provided informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

K.G. Razumovsky Moscow State University of Technologies and Management

Moscow, 109004, Russia

Location

Central Study Contacts

Igor A. Nikitin, Doctor of Technical Sciences

CONTACT

+7(495)8001200; i.nikitin@mgutm.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Department of Biotechnology of Food Products from Plant and Animal Raw Materials

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)