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

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

Status: Enrolling

Conditions: Stress (Psychology); Stress

Treatments: Dietary Supplement: Functional Bar; Dietary Supplement: Placebo Bar

Study type: Interventional

Funder types: Other

Identifiers

NCT07585422

MSUTM_001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 34 estimated patients

Sex: Female

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Functional Bar

Experimental group

Description:

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

Treatment:

Dietary Supplement: Functional Bar

Placebo Bar

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Bar