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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554954
• Other study ID #: S1
• Status: Completed
• Start date: August 2, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2020
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Locations

Country	Name	City	State
Singapore	Investigational Medical Unit (IMU)	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Dashti HS, Scheer FA, Jacques PF, Lamon-Fava S, Ordovás 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 1
Primary	Sleep Quality Assessment 2	Sleep evaluation questionnaire; Score: 0-56 (arbitrary unit) Lower score suggests better sleep	Day 1
Primary	Dietary Assessment	Food Frequency Questionnaire (FFQ)	Day 1
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.	Day 3
Primary	Blood Amino Acid Concentration (Plasma Tryptophan)	Amino acid analysis on collected blood serum for blood amino acid profile.	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.	Day 3
Primary	Sleep Quality Assessment 1 (Sleep Duration)	Pittsburgh sleep quality index (PSQI); Sleep duration (hours)	Day 1
Primary	Sleep Quality Assessment 1 (Sleep Latency)	Pittsburgh sleep quality index (PSQI); Sleep latency (minutes)	Day 1
Primary	Sleep Quality Assessment 1 (Sleep Efficiency)	Pittsburgh sleep quality index (PSQI); Sleep efficiency (%)	Day 1
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	Day 1
Secondary	Anthropometric Measurements 1	Height (kg)	Day 1
Secondary	Anthropometric Measurements 2	Weight (kg)	Day 1
Secondary	Anthropometric Measurements 3	Waist circumference (cm)	Day 1
Secondary	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
Secondary	Perceived Stress Assessment	Perceived stress assessment (PSS) questionnaire; Score: 0-40 (arbitrary unit; au) A higher score indicates higher perceived stress	Day 1
Secondary	Blood Lipid and Glucose Profile	Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration	Day 1
Secondary	Plasma Carotenoids Concentration	High performance liquid chromatography quantitative analyses of carotenoids in plasma samples	Day 1