Impact of Evening Snacks and Pre-Breakfast Intake on Sleep, Heart Rate Variability, and Stress Markers in Healthy Males.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Post dinner snack, Pre-Breakfast-1, Pre-Breakfast-2, Pre-Breakfast-3.
- Who it may be relevant to
- Registry conditions: Circadian Rhythm. Basic parameters: 30 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Dietary supplement Post dinner snack
one walnut, 2 cashews, 2 almonds, and 2 pistachios. - Dietary supplement Pre-Breakfast-1
Prepackaged dose of 25 peanuts. - Dietary supplement Pre-Breakfast-2
Prepackaged dose of 25 raisins - Dietary supplement Pre-Breakfast-3
Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast.
Primary outcome measures
- Heart Rate Variability [Time frame: Baseline]
- Heart Rate Variability [Time frame: 3 weeks]
- Determination of sleep quality [Time frame: Baseline]
- Determination of sleep quality [Time frame: 3 weeks]
- Serum Cortisol [Time frame: Baseline]
- Serum Cortisol [Time frame: 3 weeks]
- Serum Interleukin-6 [Time frame: Baseline]
- Serum Interleukin-6 [Time frame: 3 weeks]
- Body Temperature [Time frame: Baseline]
- Body Temperature [Time frame: 3 weeks]
Secondary outcome measures (12)
- Blood pressure [Time frame: Baseline]
- Blood pressure [Time frame: 3 weeks]
- Heart rate [Time frame: Baseline]
- Heart rate [Time frame: 3 weeks]
- lipid profile [Time frame: Baseline]
- lipid profile [Time frame: 3 weeks]
- Short Multidimensional Inventory Lifestyle-SMILE C [Time frame: baseline]
- Short Multidimensional Inventory Lifestyle-SMILE C [Time frame: 3 weeks]
- Liver Function Test [Time frame: baseline]
- Liver Function Test [Time frame: 3 weeks]
- Renal function test [Time frame: base line]
- Renal function test [Time frame: 3 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Pakistan · 1 center
- Imran Amjad — Islamabad
Identifiers
NCT: NCT06480305 · IRC/24/1037 Humaira Fayyaz