Effect Of Post Dinner Snack and Pre-Breakfast Consumption on Sleep Quality, Heart Rate Variability, Temperature, Interleukin-6, And Cortisol Levels in Healthy Males.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Body Temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No comorbidities like CVS, neurological, respiratory, liver and kidney diseases
- •No skin allergy
排除标准
- •Individuals with any comorbidities (Heart, liver , kidney, respiratory diseases)
- •Individuals on any Medication
- •Individuals with diagnosed insomnia
- •Obese individual with BMI greater then 30
- •Diagnosed patients with stress and anxiety
- •Individuals with fever
结局指标
主要结局
Body Temperature
时间窗: 3 weeks
Participants will be instructed to record their body temperature before getting up from bed in the morning by a digital thermometer. the body temperature is considered normal between 97 F (36.1 C) and 99 F (37.2 C).
Determination of sleep quality
时间窗: 3 weeks
For sleep, the Pittsburgh Sleep Quality Index (PSQI) a self-rated questionnaire, will be used to assess sleep quality. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The sub-scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Heart Rate Variability
时间窗: 3 weeks
The data will be collected from the Fitbit wristband and will be analyzed through the HRV time-domain, frequency domain methods. The values of high-frequency (HF) measure (power in the range of 0.15-0.4 Hz) will be considered normal. The values near 0.15Hz will be considered as reflecting sympathetic dominance and values of 0.4Hz will be considered good reflecting parasympathetic dominance. The low-frequency (LF) (power in the range: 0.04-0.15 Hz). VLF's Very Low-Frequency power band is between 0.003 Hz and 0.05 Hz. The LF/HF ratio reflects the balance between PNS and the sympathetic nervous system activity. The normal values are 2.2 ± 3.4 Time domain measurements include: SDNN: values below 50 ms will be classified as unhealthy, values of 50-100 ms have compromised health, and above 100 ms are healthy RMSSD;RMSSD (ms) 20-89ms NN50:103.40 ms is the normal value. The values below 103.40 will be considered as high risk.
Serum Cortisol
时间窗: 3 weeks
Quantitative determination of cortisol concentrations in serum will be done by using a cortisol ELISA Kit. The measurement will be done in the morning. range of serum cortisol in the morning is from 10 to 20 micrograms per deciliter. A serum level of 10 micrograms per deciliter will be considered as low levels and a serum level coming up to 20 micrograms per deciliter will be considered as high; the higher the level the higher the stress level.
Serum Interleukin-6
时间窗: 3 weeks
Quantitative determination of interleukin-6 concentrations in serum will be done by using an interleukin-6 ELISA Kit. The measurement will be done in the morning. The level of Serum Interleukin-6 is from 7-18pg/ml. A serum level of 7 pg/ml of Serum Interleukin-6 will be considered low levels and a serum level coming to 18/ml will be considered as high; the higher the level the higher the stress level.
次要结局
- Short Multidimensional Inventory Lifestyle-SMILE C(3 weeks)
- C reactive protein(3 weeks)
- Heart rate(3 weeks)
- Liver Function Test(3 weeks)
- Renal function test(3 weeks)
- Blood pressure(3 weeks)
- lipid profile(3 weeks)
- Depression Anxiety Stress Scales(3 weeks)