An interventional study of Post dinner snack and Pre-Breakfast-1 in Circadian Rhythm, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to male participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Riphah International University · Not applicable, Interventional, and Basic science
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.
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.
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Exclusion Criteria:
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.
Dietary Supplement: Post dinner snack
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.
Dietary Supplement: Post dinner snack · Dietary Supplement: Pre-Breakfast-1
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.
Dietary Supplement: Post dinner snack · Dietary Supplement: Pre-Breakfast-2
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.
Dietary Supplement: Post dinner snack · Dietary Supplement: Pre-Breakfast-3
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.
The Group B2 participants will consume a prepackaged dose of 25 peanuts. Along with Pre-breakfast but no post-dinner snack.
Dietary Supplement: Pre-Breakfast-1
The Group B3 participants will consume a prepackaged dose of 25 raisins. Along with Pre-breakfast but No Post dinner snack.
Dietary Supplement: Pre-Breakfast-2
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.
Dietary Supplement: Pre-Breakfast-3
one walnut, 2 cashews, 2 almonds, and 2 pistachios.
Prepackaged dose of 25 peanuts.
Prepackaged dose of 25 raisins
Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 3 weeks
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.
Time frame: 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.
Time frame: 3 weeks
Heart rate
Data will be collected from Fitbit wrist band.
Time frame: Baseline
Heart rate
Data will be collected from Fitbit wrist band.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks
Plan to share: No
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Started Aug 2024 (actual). Primary completion is estimated for Feb 2025, 6 months after the start.
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