AzTrials
AzTrials

SleepNCT03554954

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

An observational study of Sleep, run by National University of Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Sleep
How many people
108 participants
Where
1 siteSingapore
Study dates
2 Aug 2018to 31 Oct 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Investigational Medical Unit (IMU)

    Singapore, 117599

Other trials in Singapore

About this study

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.

Read the 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.

Conditions
Sleep
Keywords
Nutrients, Diet, Sleep Quality, Middle-aged adults, Older adults
Medical subject headings
Sleep Initiation and Maintenance Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. Sleep Quality Assessment 2

    Sleep evaluation questionnaire

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

    Measured: Day 1

  3. Dietary Assessment

    Food Frequency Questionnaire (FFQ)

    Measured: Day 1

  4. 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.

    Measured: Day 3

  5. Blood Amino Acid Concentration (Plasma Tryptophan)

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

    Measured: Day 1

  6. 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.

    Measured: Day 3

  7. Sleep Quality Assessment 1 (Sleep Duration)

    Pittsburgh sleep quality index (PSQI)

    Sleep duration (hours)

    Measured: Day 1

  8. Sleep Quality Assessment 1 (Sleep Latency)

    Pittsburgh sleep quality index (PSQI)

    Sleep latency (minutes)

    Measured: Day 1

  9. Sleep Quality Assessment 1 (Sleep Efficiency)

    Pittsburgh sleep quality index (PSQI)

    Sleep efficiency (%)

    Measured: Day 1

Secondary outcomes (8)

  1. Blood Pressure

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

    Measured: Day 1

  2. Anthropometric Measurements 1

    Height (kg)

    Measured: Day 1

  3. Anthropometric Measurements 2

    Weight (kg)

    Measured: Day 1

  4. Anthropometric Measurements 3

    Waist circumference (cm)

    Measured: Day 1

  5. Skin Carotenoid Status

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

    Measured: Day 1

  6. Perceived Stress Assessment

    Perceived stress assessment (PSS) questionnaire

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

    Measured: Day 1

  7. Blood Lipid and Glucose Profile

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

    Measured: Day 1

  8. Plasma Carotenoids Concentration

    High performance liquid chromatography quantitative analyses of carotenoids in plasma samples

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start2 Aug 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554954
Sponsor's protocol ID
S1
Status last verified
May 2020
First submitted
22 Apr 2018
Last updated
1 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 26412328

  • 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.

    PubMed 24743442

  • 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.

    PubMed 26567190

  • 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.

    PubMed 36842956

  • 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.

    PubMed 33358716

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep, run by National University of Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality Assessment 1 (GSS) (time frame: Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554954, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in