NCT03554954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 1, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

April 22, 2018

Results QC Date

April 22, 2020

Last Update Submit

May 17, 2020

Conditions

Keywords

NutrientsDietSleep QualityMiddle-aged adultsOlder adults

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

Secondary Outcomes (8)

  • Blood Pressure

    Day 1

  • Anthropometric Measurements 1

    Day 1

  • Anthropometric Measurements 2

    Day 1

  • Anthropometric Measurements 3

    Day 1

  • Skin Carotenoid Status

    Day 1

  • +3 more secondary outcomes

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Medical Unit (IMU)

Singapore, 117599, Singapore

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Serum

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Dr. Kim Jung Eun
Organization
National University of Singapore

Study Officials

  • Jung Eun Kim, PhD, RD

    NUS (Chemistry, FST)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 22, 2018

First Posted

June 13, 2018

Study Start

August 2, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

June 1, 2020

Results First Posted

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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

Locations