Circadian RhythmNCT06480305
Impact of Evening Snacks and Pre-Breakfast Intake on Sleep, Heart Rate Variability, and Stress Markers in Healthy Males.
A study testing Post dinner snack, Pre-Breakfast-1 and Pre-Breakfast-2 in people with Circadian Rhythm, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm
- What is being tested?
- Post dinner snack, Pre-Breakfast-1 and Pre-Breakfast-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- No comorbidities like CVS, neurological, respiratory, liver and kidney diseases
- No skin allergy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Imran Amjad
Islamabad, Punjab Province, 46000
imran amjad, PHD*, 03334503754, imran.amjad@riphah.edu.pk
About this study
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.
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.
Read the 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.
- Conditions
- Circadian Rhythm
- Being tested
- Post dinner snack, Pre-Breakfast-1, Pre-Breakfast-2, Pre-Breakfast-3
- Keywords
- sleep, Heart Rate Variability, stress, cortisol, Interleukin-6, post dinner snack, prebreakfast, nuts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post dinner snackDietary supplement
one walnut, 2 cashews, 2 almonds, and 2 pistachios.
Pre-Breakfast-1Dietary supplement
Prepackaged dose of 25 peanuts.
Pre-Breakfast-2Dietary supplement
Prepackaged dose of 25 raisins
Pre-Breakfast-3Dietary supplement
Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Pre-breakfast and post dinner snack (A1) | Active comparator | 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. Receives: Dietary Supplement: Post dinner snack |
| Pre-breakfast and post dinner snack (A2) | Experimental | 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. Receives: Dietary Supplement: Post dinner snack; Dietary Supplement: Pre-Breakfast-1 |
| Pre-breakfast and post dinner snack (A3) | Experimental | 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. Receives: Dietary Supplement: Post dinner snack; Dietary Supplement: Pre-Breakfast-2 |
| Pre-breakfast and post dinner snack (A4) | Experimental | 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. Receives: Dietary Supplement: Post dinner snack; Dietary Supplement: Pre-Breakfast-3 |
| Pre-breakfast but No Post dinner snack (B1) | No intervention | 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 | The Group B2 participants will consume a prepackaged dose of 25 peanuts. Along with Pre-breakfast but no post-dinner snack. Receives: Dietary Supplement: Pre-Breakfast-1 |
| Pre-breakfast but No Post dinner snack (B3) | Experimental | The Group B3 participants will consume a prepackaged dose of 25 raisins. Along with Pre-breakfast but No Post dinner snack. Receives: Dietary Supplement: Pre-Breakfast-2 |
| Pre-breakfast but No Post dinner snack (B4) | Experimental | 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. Receives: Dietary Supplement: Pre-Breakfast-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
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.
Measured: Baseline
Heart Rate Variability
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.
Measured: 3 weeks
Determination of sleep quality
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.
Measured: Baseline
Determination of sleep quality
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.
Measured: 3 weeks
Serum Cortisol
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.
Measured: Baseline
Serum Cortisol
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.
Measured: 3 weeks
Serum Interleukin-6
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.
Measured: Baseline
Serum Interleukin-6
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.
Measured: 3 weeks
Body Temperature
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).
Measured: Baseline
Body Temperature
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).
Measured: 3 weeks
Secondary outcomes (16)
Blood pressure
Data will be collected from the Fitbit wristband. A blood pressure of 120/80 will be considered normal. A blood pressure of 130/ 85 will be considered high.
Measured: Baseline
Blood pressure
Data will be collected from the Fitbit wristband. A blood pressure of 120/80 will be considered normal. A blood pressure of 130/ 85 will be considered high.
Measured: 3 weeks
Heart rate
Data will be collected from Fitbit wrist band.
Measured: Baseline
Heart rate
Data will be collected from Fitbit wrist band.
Measured: 3 weeks
lipid profile
Data will be collected from blood samples. The optimal or target level for each part of the standard lipid test is listed below:
Total cholesterol: Below 200 mg/dL HDL cholesterol: Above 60 mg/dL LDL cholesterol: Below 100 mg/dL Triglycerides: Below 150 mg/dL values of the Total cholesterol at 190-200 mg/dl will be considered as borderline and those greater than 210 will be considered as high.
Values of HDL cholesterol Above 60 mg/dLwill be considered good and values lower than 60 mg/dL will be considered bad Values of LDL cholesterol lower than 100 mg/dL will be considered good and higher Values of more than 100 mg/dL will be considered as bad.
Values of Triglycerides below 150 mg/dL will be considered good and higher than 150 mg/dL will be considered bad
Measured: Baseline
lipid profile
Data will be collected from blood samples. The optimal or target level for each part of the standard lipid test is listed below:
Total cholesterol: Below 200 mg/dL HDL cholesterol: Above 60 mg/dL LDL cholesterol: Below 100 mg/dL Triglycerides: Below 150 mg/dL values of the Total cholesterol at 190-200 mg/dl will be considered as borderline and those greater than 210 will be considered as high.
Values of HDL cholesterol Above 60 mg/dLwill be considered good and values lower than 60 mg/dL will be considered bad Values of LDL cholesterol lower than 100 mg/dL will be considered good and higher Values of more than 100 mg/dL will be considered as bad.
Values of Triglycerides below 150 mg/dL will be considered good and higher than 150 mg/dL will be considered bad
Measured: 3 weeks
Short Multidimensional Inventory Lifestyle-SMILE C
Multidimensional measure of lifestyle. It comprises 27 items. Answers are measured through a 4-point Likert scale, and scores are calculated by summing the responses (some questions have inverted score). The higher the SMILE score, the healthier the lifestyle pattern.
Measured: baseline
Short Multidimensional Inventory Lifestyle-SMILE C
Multidimensional measure of lifestyle. It comprises 27 items. Answers are measured through a 4-point Likert scale, and scores are calculated by summing the responses (some questions have inverted score). The higher the SMILE score, the healthier the lifestyle pattern.
Measured: 3 weeks
Liver Function Test
Data will be collected from blood samples. The optimal or target level for each part of the standard Liver test is listed below:
Alanine aminotransferase(ALT): 7-55U/L Aspartate aminotransferase(AST):8-48U/L Alkaline phosphatase(ALP): 45-115U/L Bilirubin: less than1mg/dL Albumin3.4-5.4g/dL
Values of Alanine aminotransferase(ALT) of 7 will U/L be considered normal and values of 55U/L will be considered high Aspartate aminotransferase(AST) value of8 U/L will be considered normal and 48U/L will be considered high Alkaline phosphatase(ALP) value of 45-U/L will be considered normal and 115 U/L will be considered high Bilirubin values of less than1mg/dL will be considered normal and more will be considered high Albumin values of 3.4 g/dL will be considered normal and more than 5.4 will be considered high
Measured: baseline
Liver Function Test
Data will be collected from blood samples. The optimal or target level for each part of the standard Liver test is listed below:
Alanine aminotransferase(ALT): 7-55U/L Aspartate aminotransferase(AST):8-48U/L Alkaline phosphatase(ALP): 45-115U/L Bilirubin: less than1mg/dL Albumin3.4-5.4g/dL Values of Alanine aminotransferase(ALT) of 7 will U/L be considered normal and values of 55U/L will be considered high Aspartate aminotransferase(AST) value of8 U/L will be considered normal and 48U/L will be considered high Alkaline phosphatase(ALP) value of 45-U/L will be considered normal and 115 U/L will be considered high Bilirubin values of less than1mg/dL will be considered normal and more will be considered high Albumin values of 3.4 g/dL will be considered normal and more than 5.4 will be considered high
Measured: 3 weeks
Renal function test
Data will be collected from blood samples. The optimal or target level for each part of the renal function tests are listed below:
serum Urea: 2.5-6-5mmol/litre. Values of 2.5-mmol/litre will be considered normal and values of 6.5mmol/L and above will be considered high Serum creatinine: 0.7-1.4mmol/dL in males. Values of 0.7mmol/dLwill be considere normal and values of 1.4mmol/dL and above will be considered high
Uric acid: 4-7 mmol/dL in males. Values of 4 mmol/litre will be considere normal. Values of 7 mmol/L and above will be considered high.
Sodium : values of 135-145mmol/L will be considere normal. Values of 145mmol/L and above will be considered high Potassium: 3.5-5.0 mmol/dL values. These values will be considere normal and values of 5.0 mmol/dL and above will be considered high Calcium: 2.2-2.6 mmol/L. These will be considered normal and values of 2.7 mmol/L and above will be considered high Phosphate : 0.9-1.3 mmol/dlitre Chloride : 96-106 mmol/dL
Measured: base line
Renal function test
Data will be collected from blood samples. The optimal or target level for each part of the renal function tests are listed below:
serum Urea: 2.5-6-5mmol/litre. Values of 2.5-mmol/litre will be considered normal and values of 6.5mmol/L and above will be considered high Serum creatinine: 0.7-1.4mmol/dL in males. Values of 0.7mmol/dLwill be considere normal and values of 1.4mmol/dL and above will be considered high
Uric acid: 4-7 mmol/dL in males. Values of 4 mmol/litre will be considere normal. Values of 7 mmol/L and above will be considered high.
Sodium : values of 135-145mmol/L will be considere normal. Values of 145mmol/L and above will be considered high Potassium: 3.5-5.0 mmol/dL values. These values will be considere normal and values of 5.0 mmol/dL and above will be considered high Calcium: 2.2-2.6 mmol/L. These will be considered normal and values of 2.7 mmol/L and above will be considered high Phosphate : 0.9-1.3 mmol/dlitre Chloride : 96-106 mmol/dL
Measured: 3 weeks
C reactive protein
will be done through the blood samples. The values are 0.3 to 1.0 mg/dL avalue of 0.3 will be considere normal and value of 1.0mg/dl and more will be considered elevated.
Measured: base line
C reactive protein
will be done through the blood samples. The values are 0.3 to 1.0 mg/dL avalue of 0.3 will be considere normal and value of 1.0mg/dl and more will be considered elevated.
Measured: 3 weeks
Depression Anxiety Stress Scales
It is a 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress. The DASS yields three subscale scores for depression, anxiety, and tension/stress. The lower the score the lower the symptoms the higher the score the higher the severity.
Measured: base line
Depression Anxiety Stress Scales
It is a 21-item self-report measure designed to assess the severity of general psychological distress and symptoms related to depression, anxiety, and stress. The DASS yields three subscale scores for depression, anxiety, and tension/stress. The lower the score the lower the symptoms the higher the score the higher the severity.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start2 Aug 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, Study director, Riphah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480305
- Sponsor's protocol ID
- IRC/24/1037 Humaira Fayyaz
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06480305
- Acronym / sponsor ID
- IRC/24/1037 Humaira Fayyaz
- Conditions
- Circadian Rhythm
- Keywords
- sleep, Heart Rate Variability, stress, cortisol, Interleukin-6, post dinner snack, prebreakfast, nuts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Pre-breakfast and post dinner snack (A1) | Active comparator | Dietary Supplement: Post dinner snackThe 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. |
| Pre-breakfast and post dinner snack (A2) | Experimental | Dietary Supplement: Post dinner snack, Dietary Supplement: Pre-Breakfast-1The 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. |
| Pre-breakfast and post dinner snack (A3) | Experimental | Dietary Supplement: Post dinner snack, Dietary Supplement: Pre-Breakfast-2The 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. |
| Pre-breakfast and post dinner snack (A4) | Experimental | Dietary Supplement: Post dinner snack, Dietary Supplement: Pre-Breakfast-3The 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. |
| Pre-breakfast but No Post dinner snack (B1) | No intervention | –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 | Dietary Supplement: Pre-Breakfast-1The Group B2 participants will consume a prepackaged dose of 25 peanuts. Along with Pre-breakfast but no post-dinner snack. |
| Pre-breakfast but No Post dinner snack (B3) | Experimental | Dietary Supplement: Pre-Breakfast-2The Group B3 participants will consume a prepackaged dose of 25 raisins. Along with Pre-breakfast but No Post dinner snack. |
| Pre-breakfast but No Post dinner snack (B4) | Experimental | Dietary Supplement: Pre-Breakfast-3The 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- No comorbidities like CVS, neurological, respiratory, liver and kidney diseases
- No skin allergy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post dinner snackone walnut, 2 cashews, 2 almonds, and 2 pistachios. | Dietary supplement | Pre-breakfast and post dinner snack (A1), Pre-breakfast and post dinner snack (A2), Pre-breakfast and post dinner snack (A3), Pre-breakfast and post dinner snack (A4) |
| Pre-Breakfast-1Prepackaged dose of 25 peanuts. | Dietary supplement | Pre-breakfast and post dinner snack (A2), Pre-breakfast but No Post dinner snack (B2) |
| Pre-Breakfast-2Prepackaged dose of 25 raisins | Dietary supplement | Pre-breakfast and post dinner snack (A3), Pre-breakfast but No Post dinner snack (B3) |
| Pre-Breakfast-3Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast. | Dietary supplement | Pre-breakfast and post dinner snack (A4), Pre-breakfast but No Post dinner snack (B4) |
Primary outcome
Heart Rate Variability
Time frame: Baseline
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.
Heart Rate Variability
Time frame: 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.
Determination of sleep quality
Time frame: Baseline
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.
Determination of sleep quality
Time frame: 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.
Serum Cortisol
Time frame: Baseline
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 Cortisol
Time frame: 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
Time frame: Baseline
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.
Serum Interleukin-6
Time frame: 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.
Body Temperature
Time frame: Baseline
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).
Body Temperature
Time frame: 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).
16 secondary outcomes
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
C reactive protein
Time frame: base line
C reactive protein
Time frame: 3 weeks
Depression Anxiety Stress Scales
Time frame: base line
Depression Anxiety Stress Scales
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Amjad study director
Riphah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post dinner snack, Pre-Breakfast-1 and Pre-Breakfast-2 in people with Circadian Rhythm, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Humaira Khan (03005344159, humaira.fayyaz@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.