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Идёт набор NCT07490782

Nutritional Intervention for College Students With Depression

Без фазы С лечением Depression - Major Depressive Disorder

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: Mediterranean Diet, Time-Restricted Eating.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder. Базовые параметры: от 18 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are: * Nutritional content, meal timing, and sleep patterns in college students with depression * Feasibility of nutritional interventions (Mediterranean Diet and Time-Restricted Eating + Mediterranean Diet) in college students with depression Researchers will compare two groups - Mediterranean Diet (Med-Diet) and Time-Restricted Eating + Mediterranean Diet (TRE + Med-Diet) - to assess adherence to the dietary interventions and overall feasibility of the study procedures. Participants will: * Complete a 2-week baseline logging diet, sleep, activity, and mood * Be randomized to Mediterranean Diet (Med-Diet) or Time-Restricted Eating + Med-Diet (TRE + Med-Diet) * Participate in dietary counseling with a registered dietitian during the 8-week intervention * Continue to log diet, wear an actigraphy device, and complete mood, sleep, and diet assessments throughout the intervention

Вмешательства

  • Поведенческое Mediterranean Diet
    Participants will receive ongoing dietary counseling, nutritional resources, and practical tips to support adoption of a Mediterranean-style dietary pattern emphasizing healthy fats (e.g., olive oil), whole grains, fruits, vegetables, and legumes, while limiting red meat and dairy products throughout the intervention period.
  • Поведенческое Time-Restricted Eating
    Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.

Первичные конечные точки

  • Sleep onset [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • Sleep offset [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • Sleep Duration [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • M10 [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • L5 [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • Relative Amplitude [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • Interdaily Stability [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • Caloric intake timing [Срок оценки: From enrollment to the end of baseline (2 weeks)]
  • MEQ Score [Срок оценки: Baseline measure in week 2]
  • PHQ9 Score [Срок оценки: Baseline measure in week 2]
Вторичные конечные точки (6)
  • Change in Sleep Duration [Срок оценки: Baseline (week 1-2) and intervention (week 9-11)]
  • Change in Relative Amplitude [Срок оценки: Baseline (week 1-2) and intervention (week 9-11)]
  • Change in Interdaily Stability [Срок оценки: Baseline (weeks 1-2) and intervention (weeks 9-11)]
  • Change in PHQ9 [Срок оценки: Baseline (week 2) and intervention (week 10)]
  • Change in PDQ-D5 Score [Срок оценки: Baseline (week 2) and intervention (week 10)]
  • Change in PSQI Score [Срок оценки: Baseline (week 2) and intervention (week 10)]

Критерии участия

Критерии включения

  • Age ≥ 18 years and enrolled as a college student
  • Symptoms of mild to moderate depression
  • Receiving treatment for depression or willing to receive treatment during study participation
  • Generally in good physical health
  • On a stable dose of any medication affecting weight, metabolism, or mental health

Критерии исключения

  • Elevated risk for suicide
  • Inability to participate safely, as determined by the study physician
  • Lifetime diagnosis of bipolar disorder, schizophrenia, or post-traumatic stress disorder
  • Current eating disorder (e.g., bulimia, anorexia nervosa, binge eating)
  • Current alcohol or substance use disorder
  • Shift work outside of class schedule in the past 30 days
  • Pregnancy or lactation
  • Treatment with an investigational drug for depression or participation in another study requiring modification of diet

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California San Diego — La Jolla

Идентификаторы

NCT: NCT07490782 · 813542

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗