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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality Assessment 1 (GSS) | Pittsburgh sleep quality index (PSQI) Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality | Day 1 |
| Sleep Quality Assessment 2 | Sleep evaluation questionnaire Score: 0-56 (arbitrary unit) Lower score suggests better sleep | Day 1 |
| Dietary Assessment | Food Frequency Questionnaire (FFQ) | Day 1 |
| Dietary Assessment 2 (Dietary Carotenoids) | 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. | Day 3 |
| Blood Amino Acid Concentration (Plasma Tryptophan) | Amino acid analysis on collected blood serum for blood amino acid profile. | Day 1 |
| Dietary Assessment 2 (Dietary Macronutrients) | 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. | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Blood pressure using electronic devices that work on the oscillometric technique. The systolic and diastolic blood pressure are both collected and reported | Day 1 |
| Anthropometric Measurements 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Study population includes middle-aged and older adults (aged 50 to 75 years) who are in general good health and not regularly having protein or vitamin supplements.
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| Name | Affiliation | Role |
|---|---|---|
| Jung Eun Kim, PhD, RD | NUS (Chemistry, FST) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Medical Unit (IMU) | Singapore | 117599 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26412328 | Result | Smagula SF, Koh WP, Wang R, Yuan JM. Chronic disease and lifestyle factors associated with change in sleep duration among older adults in the Singapore Chinese Health Study. J Sleep Res. 2016 Feb;25(1):57-61. doi: 10.1111/jsr.12342. | |
| 24743442 | Result | Pan A, De Silva DA, Yuan JM, Koh WP. Sleep duration and risk of stroke mortality among Chinese adults: Singapore Chinese health study. Stroke. 2014 Jun;45(6):1620-5. doi: 10.1161/STROKEAHA.114.005181. Epub 2014 Apr 17. |
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Electronic copies of the data with identifiable participant information will be kept on a secure computer with access limited to the principal investigator and her research staff. All data will be de-identified prior to statistical analyses
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| ID | Title | Description |
|---|---|---|
| FG000 | Food/Nutrient Intake and Sleep Quality | Cross-sectional research design:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Association Between Food/Nutrient Intake and Sleep Quality | This is a cross-sectional study and it does not have an arm/group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Quality Assessment 1 (GSS) | Pittsburgh sleep quality index (PSQI) Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
1 Year.
Definition is the same as clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Association Between Food/Nutrient Intake and Sleep Quality | This is a cross-sectional study and it does not have an arm/group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kim Jung Eun | National University of Singapore | 65161136 | +65 | fstkje@nus.edu.sg |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 31, 2019 | Apr 22, 2020 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Whole Blood, Serum
| Sleep Quality Assessment 1 (Sleep Duration) |
Pittsburgh sleep quality index (PSQI) Sleep duration (hours) |
| Day 1 |
| Sleep Quality Assessment 1 (Sleep Latency) | Pittsburgh sleep quality index (PSQI) Sleep latency (minutes) | Day 1 |
| Sleep Quality Assessment 1 (Sleep Efficiency) | Pittsburgh sleep quality index (PSQI) Sleep efficiency (%) | Day 1 |
Height (kg)
| Day 1 |
| Anthropometric Measurements 2 | Weight (kg) | Day 1 |
| Anthropometric Measurements 3 | Waist circumference (cm) | Day 1 |
| Skin Carotenoid Status | Measure with resonance Raman spectroscopy. A higher score is indicative of raised skin carotenoid levels and hence, a better outcome | Day 1 |
| Perceived Stress Assessment | Perceived stress assessment (PSS) questionnaire Score: 0-40 (arbitrary unit; au) A higher score indicates higher perceived stress | Day 1 |
| Blood Lipid and Glucose Profile | Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration | Day 1 |
| Plasma Carotenoids Concentration | High performance liquid chromatography quantitative analyses of carotenoids in plasma samples | Day 1 |
| 26567190 | Result | Dashti HS, Scheer FA, Jacques PF, Lamon-Fava S, Ordovas JM. Short sleep duration and dietary intake: epidemiologic evidence, mechanisms, and health implications. Adv Nutr. 2015 Nov 13;6(6):648-59. doi: 10.3945/an.115.008623. Print 2015 Nov. |
| 36842956 | Derived | Tan D, Sutanto CN, Lin JWX, Toh DWK, Le KA, Kim JE. Measures of carbohydrate quality and their association with diet quality and cardiometabolic health outcomes in Singapore middle-aged and older adults. Nutr Metab Cardiovasc Dis. 2023 Apr;33(4):778-788. doi: 10.1016/j.numecd.2023.01.008. Epub 2023 Jan 16. |
| 33358716 | Derived | Toh DWK, Sutanto CN, Loh WW, Lee WY, Yao Y, Ong CN, Kim JE. Skin carotenoids status as a potential surrogate marker for cardiovascular disease risk determination in middle-aged and older adults. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):592-601. doi: 10.1016/j.numecd.2020.10.016. Epub 2020 Oct 26. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Sleep Quality Assessment 2 | Sleep evaluation questionnaire Score: 0-56 (arbitrary unit) Lower score suggests better sleep | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
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| Primary | Dietary Assessment | Food Frequency Questionnaire (FFQ) | Not Posted | Day 1 | Participants |
| Primary | Dietary Assessment 2 (Dietary Carotenoids) | 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. | Posted | Mean | Standard Deviation | mg | Day 3 |
|
|
|
| Primary | Blood Amino Acid Concentration (Plasma Tryptophan) | Amino acid analysis on collected blood serum for blood amino acid profile. | Posted | Mean | Standard Deviation | nmol/mL | Day 1 |
|
|
|
| Primary | Dietary Assessment 2 (Dietary Macronutrients) | 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. | Posted | Mean | Standard Deviation | percentage of energy intake | Day 3 |
|
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| Primary | Sleep Quality Assessment 1 (Sleep Duration) | Pittsburgh sleep quality index (PSQI) Sleep duration (hours) | Posted | Mean | Standard Deviation | hours | Day 1 |
|
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| Primary | Sleep Quality Assessment 1 (Sleep Latency) | Pittsburgh sleep quality index (PSQI) Sleep latency (minutes) | Posted | Mean | Standard Deviation | minutes | Day 1 |
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| Primary | Sleep Quality Assessment 1 (Sleep Efficiency) | Pittsburgh sleep quality index (PSQI) Sleep efficiency (%) | Posted | Mean | Standard Deviation | percentage of sleep from time in bed | Day 1 |
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| Secondary | Blood Pressure | Blood pressure using electronic devices that work on the oscillometric technique. The systolic and diastolic blood pressure are both collected and reported | Posted | Mean | Standard Deviation | mmHg | Day 1 |
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| Secondary | Anthropometric Measurements 1 | Height (kg) | Posted | Mean | Standard Deviation | cm | Day 1 |
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| Secondary | Anthropometric Measurements 2 | Weight (kg) | Posted | Mean | Standard Deviation | kg | Day 1 |
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| Secondary | Anthropometric Measurements 3 | Waist circumference (cm) | Posted | Mean | Standard Deviation | cm | Day 1 |
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| Secondary | Skin Carotenoid Status | Measure with resonance Raman spectroscopy. A higher score is indicative of raised skin carotenoid levels and hence, a better outcome | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| Secondary | Perceived Stress Assessment | Perceived stress assessment (PSS) questionnaire Score: 0-40 (arbitrary unit; au) A higher score indicates higher perceived stress | Current data is the overall mean of the subjects that has participated. Comparison analysis is incomplete and still in progress. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
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| Secondary | Blood Lipid and Glucose Profile | Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration | Posted | Mean | Standard Deviation | mmol/L | Day 1 |
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| Secondary | Plasma Carotenoids Concentration | High performance liquid chromatography quantitative analyses of carotenoids in plasma samples | Posted | Mean | Standard Deviation | mg/L | Day 1 |
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| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
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| D001523 |
| Mental Disorders |
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| Total Protein |
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| LDL-cholesterol |
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| HDL-cholesterol |
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| Glucose |
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