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Идёт набор NCT07292610

Impact of Nut Consumption on Mental Health in Young Adults

Без фазы С лечением Depression Disorder Anxiety Mental Health Stress

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: mixed nuts. Group A, mixed nuts. Group B, control group.
Кому может быть актуально
Состояния в реестре: Depression Disorder, Anxiety, Mental Health, Stress. Базовые параметры: 18 лет — 24 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

Impact of Nut Consumption on Mental Health in Young Adults: a Randomized Controlled Trial

Обзор

Nuts have a high nutrient density, and numerous studies have reported their cardiometabolic benefits. Although observational studies in adults have indicated a potential link between nut consumption and improved mental health, there is still insufficient evidence from experimental studies to draw firm conclusions about this association.

Подробное описание

Nuts are widely recognized for their high nutrient density and their multiple reported cardiometabolic benefits. They are rich in monounsaturated (MUFAs) and polyunsaturated (PUFAs) fatty acids (including omega-3 alpha-linolenic acid and omega-6 linoleic acid) as well as antioxidants and compounds with anti inflammatory properties. Observational studies in adults have suggested a potential association between nut consumption and improved mental health, including a reduced risk of depression and enhanced mood. However, evidence from experimental studies remains limited and often inconclusive.

Early adulthood (ages 18-24) represents a critical developmental period marked by substantial physical, psychological, and social changes, and it is also a stage during which mental health problems commonly emerge.

The Nuts4Brain-RCT will investigate the impact of a 6-month mixed-nut intervention on mental health symptoms, cognitive functioning, sleep quality, overall well-being, health-related quality of life, and biochemical mediators of brain function and mental health in young adults.

Вмешательства

  • Пищевая добавка mixed nuts. Group A
    Participants will be instructed to consume a single daily dose of nuts (30 g/day of mixed nuts). Nuts will be provided free of charge for the entire study period (6 moths). The participants will be instructed to incorporate nuts into their regular diet and consume them in any way they prefer. Upon completion of the intervention, participants will be instructed to continue their usual dietary and lifestyle habits, without any specific restrictions or incentives directed toward nut consumption. A
  • Пищевая добавка mixed nuts. Group B
    Participants will be instructed to consume two daily doses of nuts (60 g/day of mixed nuts). Nuts will be provided free of charge for the entire study period (6 months). The participants will be instructed to incorporate nuts into their regular diet and consume them in any way they prefer.Upon completion of the intervention, participants will be instructed to continue their usual dietary and lifestyle habits, without any specific restrictions or incentives directed toward nut consumption. After
  • Другое control group
    Participants will be instructed to maintain their regular diet without any specific dietary instructions or intervention.

Первичные конечные точки

  • Depression [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Anxiety [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Stress [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Episodic memory [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Working memory [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Cognitive flexibility [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Processing speed [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Inhibitory control and attention [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Brain Derived Neurotrophic Factor [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
Вторичные конечные точки (12)
  • Sleep quality [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Health-related quality of life (HRQL) [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Inflammatory biomarkers [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Concentration of vitamins and minerals [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Body image [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Screen time [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Social media addiction [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Sociodemographic [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Drugs consumption [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Adherence to the Mediterranean Diet [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Resilience [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]
  • Risk of eating disorders [Срок оценки: "Day 0", "Month 3", "Month 6", "Month 12"]

Критерии участия

Participants must meet all the following criteria to be considered eligible for selection and randomization:

Критерии включения

  • Age: Participants must be between 18 and 25 years old.
  • Academic Status: Participants must be enrolled as university students.
  • Field of Study: Participants may come from any academic program offered at the Cuenca Campus, including Nursing, Social Work, Education, Fine Arts, Engineering, Journalism, and Teaching.

Participants will be excluded from the study if they have any of the following conditions, based on self-reported information:

Критерии исключения

  • Allergies: Known nut allergy.
  • Self-reported cardiovascular, metabolic, gastrointestinal or mental health disorder.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Испания · 1 центр
  • Health and Social Research Center. University of Castilla-La Mancha — Cuenca

Публикации

  • Mesas AE, Peral-Martinez F, Olivo-Martins-de-Passos T, Jimenez-Lopez E, Beneit N, Martinez-Ortega IA, Diaz-Goni V, Herraiz-Garrote S, Martinez-Garcia I, Casanova-Rodriguez D, Rodriguez-Gutierrez E, Bizzozero-Peroni B, Ballesta-Castillejos A, Cekrezi S, Marcilla-Toribio I, Nunez de Arenas-Arroyo S, Alvarez-Herraiz C, Maia CSC, Machado SP, Oliveira LFN, Serrano-Martinez S, Martinez-Madrid V, Caldero PMID 41753948

Идентификаторы

NCT: NCT07292610 · SBPLY/23/180225/000177 · SBPLY/23/180225/000177

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗