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Идёт набор NCT06480305

Impact of Evening Snacks and Pre-Breakfast Intake on Sleep, Heart Rate Variability, and Stress Markers in Healthy Males.

Без фазы С лечением Circadian Rhythm

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: Post dinner snack, Pre-Breakfast-1, Pre-Breakfast-2, Pre-Breakfast-3.
Кому может быть актуально
Состояния в реестре: Circadian Rhythm. Базовые параметры: 30 лет — 50 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Официальное название

Effect Of Post Dinner Snack and Pre-Breakfast Consumption on Sleep Quality, Heart Rate Variability, Temperature, Interleukin-6, And Cortisol Levels in Healthy Males.

Обзор

The body has a natural 24-hour rhythm. This rhythm affects factors like body temperature, sleep and Heart Rate Variability (HRV). Dietary choices influence these physiological processes of the body. Poor sleep quality can increase stress and raise levels of a hormone called cortisol, affecting our heart and insulin levels. Heart rate variability (HRV) which is the time between heartbeats, is also influenced by sleep and the body's rhythm. Lower HRV levels have been linked to heart and mental health issues. Little research is present on the effects of post-dinner snacks and pre-breakfast interventions on sleep quality, Heart Rate Variability (HRV), temperature, Interleukin-6, and cortisol levels. It is hypothesised that eating a post-dinner snack and first pre-breakfast will affect sleep quality, heart rate variability, IL -6, cortisol levels and temperature in healthy males.

Подробное описание

The body's internal clock, circadian rhythms, works on a 24-hour cycle and is managed by a part of the brain called the hypothalamus. These rhythms control various bodily functions like temperature, hunger, emotions, and even our sleep-wake cycle. During sleep, hormones like cortisol, growth hormone, and insulin influence processes such as glucose metabolism. For instance, insulin levels drop while we sleep to allow the body to use stored energy, but rise again before waking. Poor sleep quality, even with adequate duration, can lead to increased stress and elevated cortisol levels, potentially affecting insulin and heart health. Heart rate variability (HRV), is the variation in time between heartbeats and is influenced by factors like stress, diet, and sleep quality. Lower HRV levels are associated with cardiovascular and mental health issues. Disruptions in the circadian sleep cycle can also affect the gut-brain axis, which involves communication between the gut and the brain via the vagus nerve. This axis influences gastrointestinal function and can impact inflammatory markers like interleukin-6 (IL-6), which in turn affect HRV and cardiovascular health. Dietary choices play a significant role in shaping the body's physiological processes. Nuts can positively impact HRV and sleep quality due to their nutrient content. A post-dinner snack consumed about three hours after dinner and a balanced pre-breakfast meal is important for maintaining stable blood sugar levels and overall health. Nuts, such as peanuts, almonds, cashews, pistachios, and walnuts, along with raisins, offer numerous health benefits. These contain fibre, protein, healthy fats, and essential nutrients that promote satiety, metabolic well-being, and digestive health. Thus this research aims to investigate the effects of post-dinner snacks and pre-breakfast interventions on HRV, sleep quality, IL-6, cortisol, and temperature. By exploring the relationship between dietary choices and physiological processes, we hope to gain insight into how to optimize health and well-being.

The participation will go through 2 assessments; at baseline and after intervention. For comparison two-way ANOVA followed by Post hoc-Tuckey test and for correlation between HRV and other parameters will be done using Pearson Correlation.

Вмешательства

  • Пищевая добавка Post dinner snack
    one walnut, 2 cashews, 2 almonds, and 2 pistachios.
  • Пищевая добавка Pre-Breakfast-1
    Prepackaged dose of 25 peanuts.
  • Пищевая добавка Pre-Breakfast-2
    Prepackaged dose of 25 raisins
  • Пищевая добавка Pre-Breakfast-3
    Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast.

Первичные конечные точки

  • Heart Rate Variability [Срок оценки: Baseline]
  • Heart Rate Variability [Срок оценки: 3 weeks]
  • Determination of sleep quality [Срок оценки: Baseline]
  • Determination of sleep quality [Срок оценки: 3 weeks]
  • Serum Cortisol [Срок оценки: Baseline]
  • Serum Cortisol [Срок оценки: 3 weeks]
  • Serum Interleukin-6 [Срок оценки: Baseline]
  • Serum Interleukin-6 [Срок оценки: 3 weeks]
  • Body Temperature [Срок оценки: Baseline]
  • Body Temperature [Срок оценки: 3 weeks]
Вторичные конечные точки (12)
  • Blood pressure [Срок оценки: Baseline]
  • Blood pressure [Срок оценки: 3 weeks]
  • Heart rate [Срок оценки: Baseline]
  • Heart rate [Срок оценки: 3 weeks]
  • lipid profile [Срок оценки: Baseline]
  • lipid profile [Срок оценки: 3 weeks]
  • Short Multidimensional Inventory Lifestyle-SMILE C [Срок оценки: baseline]
  • Short Multidimensional Inventory Lifestyle-SMILE C [Срок оценки: 3 weeks]
  • Liver Function Test [Срок оценки: baseline]
  • Liver Function Test [Срок оценки: 3 weeks]
  • Renal function test [Срок оценки: base line]
  • Renal function test [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

  • Healthy
  • No comorbidities like CVS, neurological, respiratory, liver and kidney diseases
  • No skin allergy

Критерии исключения

  • Individuals with any comorbidities (Heart, liver , kidney, respiratory diseases)
  • Individuals on any Medication
  • Individuals with diagnosed insomnia
  • Obese individual with BMI greater then 30
  • Smokers
  • Diagnosed patients with stress and anxiety
  • Individuals with fever

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
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Пакистан · 1 центр
  • Imran Amjad — Islamabad

Идентификаторы

NCT: NCT06480305 · IRC/24/1037 Humaira Fayyaz

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗