ClinicalTrials.Veeva

Menu

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

R

Riphah International University

Status

Enrolling

Conditions

Circadian Rhythm

Treatments

Dietary Supplement: Pre-Breakfast-2
Dietary Supplement: Pre-Breakfast-3
Dietary Supplement: Pre-Breakfast-1
Dietary Supplement: Post dinner snack

Study type

Interventional

Funder types

Other

Identifiers

NCT06480305
IRC/24/1037 Humaira Fayyaz

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Male

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 8 patient groups

Pre-breakfast and post dinner snack (A1)
Active Comparator group
Description:
The Group A1 participants will not receive anything except for consuming a post-dinner snack. This is the control group for Prebreakfast and post-dinner snack groups.
Treatment:
Dietary Supplement: Post dinner snack
Pre-breakfast and post dinner snack (A2)
Experimental group
Description:
The Group A2 participants will consume post-dinner snacks consisting of 7-8 peanuts, one walnut, 2 cashews, 2 almonds, and 2 pistachios, and a prepackaged dose of 25 peanuts as a pre-breakfast snack.
Treatment:
Dietary Supplement: Post dinner snack
Dietary Supplement: Pre-Breakfast-1
Pre-breakfast and post dinner snack (A3)
Experimental group
Description:
The Group A3 participants will consume post-dinner snacks consisting of 7-8 peanuts, one walnut, 2 cashews, 2 almonds, and 2 pistachios, and a prepackaged dose of 25 raisins as a pre-breakfast snack.
Treatment:
Dietary Supplement: Post dinner snack
Dietary Supplement: Pre-Breakfast-2
Pre-breakfast and post dinner snack (A4)
Experimental group
Description:
The Group A4 participants will consume post-dinner snacks consisting of 7-8 peanuts, one walnut, 2 cashews, 2 almonds, and 2 pistachios, and a prepackaged dose of 5 peanuts on one day and 25 raisins as a pre-breakfast snack on the other day.
Treatment:
Dietary Supplement: Post dinner snack
Dietary Supplement: Pre-Breakfast-3
Pre-breakfast but No Post dinner snack (B1)
No Intervention group
Description:
The Group B1 participants will not receive anything not even pre-breakfast. This is the control group for Pre-breakfast and no post-dinner snacks.
Pre-breakfast but No Post dinner snack (B2)
Experimental group
Description:
The Group B2 participants will consume a prepackaged dose of 25 peanuts. Along with Pre-breakfast but no post-dinner snack.
Treatment:
Dietary Supplement: Pre-Breakfast-1
Pre-breakfast but No Post dinner snack (B3)
Experimental group
Description:
The Group B3 participants will consume a prepackaged dose of 25 raisins. Along with Pre-breakfast but No Post dinner snack.
Treatment:
Dietary Supplement: Pre-Breakfast-2
Pre-breakfast but No Post dinner snack (B4)
Experimental group
Description:
The Group A4 participants of the group will prepackaged dose of 25 peanuts one and the other day will consume 25 raisins. They alternate peanuts and raisins for the period of intervention. Along with Pre-breakfast but No Post dinner snack.
Treatment:
Dietary Supplement: Pre-Breakfast-3

Trial contacts and locations

1

Loading...

Central trial contact

Humaira Khan; Shazia Ali

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems