Clinical trial NCT06480305: Impact of Evening Snacks and Pre-Breakfast Intake on Sleep, Heart Rate Variability, and Stress Markers in Healthy Males.
Official title: Effect Of Post Dinner Snack and Pre-Breakfast Consumption on Sleep Quality, Heart Rate Variability, Temperature, Interleukin-6, And Cortisol Levels in Healthy Males.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circadian Rhythm
Keywords: sleep
Heart Rate Variability
stress
cortisol
Interleukin-6
post dinner snack
prebreakfast
nuts
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 80
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Baseline
measure: Heart Rate Variability
timeFrame: 3 weeks
measure: Determination of sleep quality
timeFrame: Baseline
measure: Determination of sleep quality
timeFrame: 3 weeks
measure: Serum Cortisol
timeFrame: Baseline
measure: Serum Cortisol
timeFrame: 3 weeks
measure: Serum Interleukin-6
timeFrame: Baseline
measure: Serum Interleukin-6
timeFrame: 3 weeks
measure: Body Temperature
timeFrame: Baseline
measure: Body Temperature
timeFrame: 3 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 3 weeks
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: 3 weeks
measure: lipid profile
timeFrame: Baseline
measure: lipid profile
timeFrame: 3 weeks
measure: Short Multidimensional Inventory Lifestyle-SMILE C
timeFrame: baseline
measure: Short Multidimensional Inventory Lifestyle-SMILE C
timeFrame: 3 weeks
measure: Liver Function Test
timeFrame: baseline
measure: Liver Function Test
timeFrame: 3 weeks
measure: Renal function test
timeFrame: base line
measure: Renal function test
timeFrame: 3 weeks
measure: C reactive protein
timeFrame: base line
measure: C reactive protein
timeFrame: 3 weeks
measure: Depression Anxiety Stress Scales
timeFrame: base line
measure: Depression Anxiety Stress Scales
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Imran Amjad
state: Punjab
Study officials:
affiliation: Riphah University
name: Imran Amjad
role: STUDY_DIRECTOR
References: