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OpenTrials
Completed

NCT Number: NCT03554954

Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population

Sleep is essential to health. Quality of sleep, measure through indexes of sleep, is related to the incidence of obesity, type 2 diabetes, cardiovascular disease, hypertension, and premature death. Sleep pattern changes as people age. They tend to have a harder time falling asleep and more trouble staying asleep than when they were younger. Studies have shown that food/nutrient intake may be associated with sleep duration, quality, and patterns. Singapore's population is aging rapidly and improving their indexes of sleep may result in their health promotion.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Medical Unit (IMU)

Singapore, 117599

About this study

Sleep is essential to health and indexes of sleep including duration, quality, and patterning are related to the incidence of chronic diseases and premature death. Changes in sleep patterns are a part of the aging process and as people age, they tend to have a harder time falling asleep and more trouble staying asleep than when they were younger. Certain cross-sectional studies have shown that food/nutrient intake may be associated with sleep duration, quality, and patterns. In the last decade, Singapore's population has grown older. However, limited research examined the association between food/nutrient intake and indexes of sleep in middle-aged and older population in Singapore. Therefore, with a growing number of elderly, studies on improving their sleep quality can play a significant role in improving their quality of life. This is a cross-sectional study and subjects require a 1-day visit (one time visit ONLY). Generally healthy middle-aged and older population will be recruited and after the phone screening and validated subjects will complete the medical history questionnaire and to be brought on the day of visit. During the visit, subjects will stay approximately 3-h to complete the testing. After completing the consent form, fasting-state blood collection and general health assessment will be conducted. Then subjects will be asked to complete the questionnaires to assess sleep quality and dietary intake.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give an informed consent
  • Age 50 to 75 years
  • Not taking dietary supplements which may impact the outcome of the interests (I.e. dietary protein and vitamin supplements)
  • Not having significant dietary changes for the past 1 year (i.e. weight loss, vegetarian diet)
  • Having sufficient venous access to allow the blood collection
  • Willing to follow the study procedure

Exclusion criteria

  • Unable to give an informed consent
  • Age < 50 years
  • Taking dietary supplements which may impact the outcome of the interest (i.e. dietary proteins and vitamin supplements)
  • Having/had significant dietary changes for the past 1 year
  • Not having sufficient venous access to allow the blood collection
  • Unwilling to follow the study procedure

Treatment and study plan

Primary outcomes

  1. Sleep Quality Assessment 1 (GSS)

    Time frame: Day 1

    Pittsburgh sleep quality index (PSQI)

    Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality

  2. Sleep Quality Assessment 2

    Time frame: Day 1

    Sleep evaluation questionnaire

    Score: 0-56 (arbitrary unit) Lower score suggests better sleep

  3. Dietary Assessment

    Time frame: Day 1

    Food Frequency Questionnaire (FFQ)

  4. Dietary Assessment 2 (Dietary Carotenoids)

    Time frame: Day 3

    3 Day 24-Hr Dietary Recall: Participants will be given a diagram showing serving sizes that they can refer to for measurements. Only 3 out of the 7 days of the week are required for the participants to record their food intake. Results are reported as the average value of the analysed nutrients (dietary carotenoids) across the 3 days the dietary data was collected.

  5. Blood Amino Acid Concentration (Plasma Tryptophan)

    Time frame: Day 1

    Amino acid analysis on collected blood serum for blood amino acid profile.

  6. Dietary Assessment 2 (Dietary Macronutrients)

    Time frame: Day 3

    3 Day 24-Hr Dietary Recall: Participants will be given a diagram showing serving sizes that they can refer to for measurements. Only 3 out of the 7 days of the week are required for the participants to record their food intake. Results are reported as the average value of the analysed nutrients (dietary fat) across the 3 days the dietary data was collected.

  7. Sleep Quality Assessment 1 (Sleep Duration)

    Time frame: Day 1

    Pittsburgh sleep quality index (PSQI)

    Sleep duration (hours)

  8. Sleep Quality Assessment 1 (Sleep Latency)

    Time frame: Day 1

    Pittsburgh sleep quality index (PSQI)

    Sleep latency (minutes)

  9. Sleep Quality Assessment 1 (Sleep Efficiency)

    Time frame: Day 1

    Pittsburgh sleep quality index (PSQI)

    Sleep efficiency (%)

Secondary outcomes

  1. Blood Pressure

    Time frame: Day 1

    Blood pressure using electronic devices that work on the oscillometric technique. The systolic and diastolic blood pressure are both collected and reported

  2. Anthropometric Measurements 1

    Time frame: Day 1

    Height (kg)

  3. Anthropometric Measurements 2

    Time frame: Day 1

    Weight (kg)

  4. Anthropometric Measurements 3

    Time frame: Day 1

    Waist circumference (cm)

  5. Skin Carotenoid Status

    Time frame: Day 1

    Measure with resonance Raman spectroscopy. A higher score is indicative of raised skin carotenoid levels and hence, a better outcome

  6. Perceived Stress Assessment

    Time frame: Day 1

    Perceived stress assessment (PSS) questionnaire

    Score: 0-40 (arbitrary unit; au) A higher score indicates higher perceived stress

  7. Blood Lipid and Glucose Profile

    Time frame: Day 1

    Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration

  8. Plasma Carotenoids Concentration

    Time frame: Day 1

    High performance liquid chromatography quantitative analyses of carotenoids in plasma samples

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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