Идёт набор NCT07497698

Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

Без фазы С лечением Sleep

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Saffron Extract, Dietary Supplement: Placebo.
Кому может быть актуально: Состояния в реестре: Sleep. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Обзор

This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of daily saffron extract supplementation (30 mg/day) for six weeks on objective and subjective sleep quality in middle-aged adults with mild-to-moderate sleep disturbances. Secondary outcomes include heart rate variability, cognitive processing speed, emotional state, perceived health status, and biochemical stress markers.

Подробное описание

Sleep disturbances are highly prevalent in middle-aged adults and are associated with impaired daytime functioning, increased cardiometabolic risk, and reduced quality of life. Pharmacological treatments may be effective but are often associated with adverse effects and dependency risk.

Saffron (Crocus sativus L.) contains bioactive compounds such as crocins and safranal, which may modulate neurotransmitter systems involved in sleep regulation, including serotonin, dopamine, and GABA pathways.

Eighty middle-aged adults with mild-to-moderate sleep disturbances will be randomly assigned to receive either 30 mg/day of standardized saffron extract or placebo for six weeks. Sleep will be objectively assessed using wrist-worn accelerometry over 14 days before and during the final weeks of intervention. Subjective sleep quality will be evaluated using validated questionnaires.

The study follows CONSORT guidelines and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice standards.

Вмешательства

Пищевая добавка Saffron Extract
Participants will receive 30 mg/day of standardized saffron extract (≥3% crocins; ≥2% safranal) for six weeks. Capsules will be taken once daily, one hour before bedtime.
Пищевая добавка Dietary Supplement: Placebo
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.

Первичные конечные точки

Objective Sleep Efficiency (%) [Срок оценки: Baseline and Week 6]

Вторичные конечные точки (10)

Total Sleep Time (hours) [Срок оценки: Baseline and Week 6]
Wake After Sleep Onset (minutes) [Срок оценки: Baseline and Week 6]
Sleep Latency (minutes) [Срок оценки: Baseline and Week 6]
Pittsburgh Sleep Quality Index (PSQI) Score [Срок оценки: Baseline, Week 4, and Week 6]
Insomnia Severity Index (ISI) Score [Срок оценки: Baseline, Week 4, and Week 6]
Epworth Sleepiness Scale (ESS) Score [Срок оценки: Baseline, Week 4, and Week 6]
Heart Rate Variability (RMSSD and SDNN) [Срок оценки: Baseline and Week 6]
Emotional State (BDI-FS, STAI, PSS-10 Scores) [Срок оценки: Baseline, Week 4, and Week 6]
Health-Related Quality of Life (SF-36 Score) [Срок оценки: Baseline, Week 4, and Week 6]
Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin) [Срок оценки: Baseline and Week 6]

Критерии участия

Критерии включения

Age 18-65 years
Mild-to-moderate sleep disturbances
BMI between 18 and 35 kg/m²
Not receiving active pharmacological or psychological treatment for sleep disorders
Willingness to comply with study procedures