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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Moscow, Rusland, 109004
- K.G. Razumovsky Moscow State University of Technologies and Management
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Functional Bar
Daily consumption of a functional date-based bar enriched with magnesium, vitamin C, and grape seed extract for 4 weeks.
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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.
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Placebo-vergelijker: Placebo Bar
Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.
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Daily consumption of a date-based bar in which all active ingredients are replaced with maltodextrin, for 4 weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Morning Salivary Cortisol Level
Tijdsspanne: Baseline and 4 weeks
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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
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Change in Perceived Stress Scale (PSS-14) score
Tijdsspanne: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MSUTM_001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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