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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Moscow, Rússia, 109004
- K.G. Razumovsky Moscow State University of Technologies and Management
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Morning Salivary Cortisol Level
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- MSUTM_001
Plano para dados de participantes individuais (IPD)
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