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

NCT06480305 | Recruiting DMC

• 1 other identifier: IRC/24/1037 Humaira Fayyaz
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm

Keywords

sleep; Heart Rate Variability; stress; cortisol; Interleukin-6; post dinner snack; prebreakfast; nuts

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  3 weeks

Secondary Outcomes (16)

• Blood pressure

  Baseline

• Blood pressure

  3 weeks

• Heart rate

  Baseline

• Heart rate

  3 weeks

• lipid profile

  Baseline

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

Dietary Supplement: Pre-Breakfast-3

Interventions

Post dinner snack DIETARY_SUPPLEMENT

one walnut, 2 cashews, 2 almonds, and 2 pistachios.

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-1 DIETARY_SUPPLEMENT

Prepackaged dose of 25 peanuts.

Pre-breakfast and post dinner snack (A2); Pre-breakfast but No Post dinner snack (B2)

Pre-Breakfast-2 DIETARY_SUPPLEMENT

Prepackaged dose of 25 raisins

Pre-breakfast and post dinner snack (A3); Pre-breakfast but No Post dinner snack (B3)

Pre-Breakfast-3 DIETARY_SUPPLEMENT

Prepackaged dose of 25 peanuts on one day and 25 raisins as a pre-breakfast.

Pre-breakfast and post dinner snack (A4); Pre-breakfast but No Post dinner snack (B4)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: male adult participants will be taken to avoid the effect of hormone of female monthly cycle on HRV data
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Imran Amjad

Islamabad, Punjab Province, 46000, Pakistan

RECRUITING

Study Officials

• Imran Amjad

  Riphah University

  STUDY DIRECTOR

Central Study Contacts

Humaira Khan

CONTACT

03005344159; humaira.fayyaz@riphah.edu.pk

Shazia Ali

CONTACT

03005001789; shazia.ali@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 28, 2024
• Study Start: August 2, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)