Clinical trial NCT03554954: Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population
Official title: Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: Nutrients
Diet
Sleep Quality
Middle-aged adults
Older adults
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sleep Quality Assessment 1 (GSS)
timeFrame: Day 1
measure: Sleep Quality Assessment 2
timeFrame: Day 1
measure: Dietary Assessment
timeFrame: Day 1
measure: Dietary Assessment 2 (Dietary Carotenoids)
timeFrame: Day 3
measure: Blood Amino Acid Concentration (Plasma Tryptophan)
timeFrame: Day 1
measure: Dietary Assessment 2 (Dietary Macronutrients)
timeFrame: Day 3
measure: Sleep Quality Assessment 1 (Sleep Duration)
timeFrame: Day 1
measure: Sleep Quality Assessment 1 (Sleep Latency)
timeFrame: Day 1
measure: Sleep Quality Assessment 1 (Sleep Efficiency)
timeFrame: Day 1
Secondary outcomes:
measure: Blood Pressure
timeFrame: Day 1
measure: Anthropometric Measurements 1
timeFrame: Day 1
measure: Anthropometric Measurements 2
timeFrame: Day 1
measure: Anthropometric Measurements 3
timeFrame: Day 1
measure: Skin Carotenoid Status
timeFrame: Day 1
measure: Perceived Stress Assessment
timeFrame: Day 1
measure: Blood Lipid and Glucose Profile
timeFrame: Day 1
measure: Plasma Carotenoids Concentration
timeFrame: Day 1
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Investigational Medical Unit (IMU)
Study officials:
affiliation: NUS (Chemistry, FST)
name: Jung Eun Kim, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.