- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03554954
Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Singapore, Singapore, 117599
- Investigational Medical Unit (IMU)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality Assessment 1 (GSS)
Time Frame: Day 1
|
Pittsburgh sleep quality index (PSQI) Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality |
Day 1
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Sleep Quality Assessment 2
Time Frame: Day 1
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Sleep evaluation questionnaire Score: 0-56 (arbitrary unit) Lower score suggests better sleep |
Day 1
|
|
Dietary Assessment
Time Frame: Day 1
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Food Frequency Questionnaire (FFQ)
|
Day 1
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Dietary Assessment 2 (Dietary Carotenoids)
Time Frame: Day 3
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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.
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Day 3
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Blood Amino Acid Concentration (Plasma Tryptophan)
Time Frame: Day 1
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Amino acid analysis on collected blood serum for blood amino acid profile.
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Day 1
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Dietary Assessment 2 (Dietary Macronutrients)
Time Frame: Day 3
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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
|
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Sleep Quality Assessment 1 (Sleep Duration)
Time Frame: Day 1
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Pittsburgh sleep quality index (PSQI) Sleep duration (hours) |
Day 1
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Sleep Quality Assessment 1 (Sleep Latency)
Time Frame: Day 1
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Pittsburgh sleep quality index (PSQI) Sleep latency (minutes) |
Day 1
|
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Sleep Quality Assessment 1 (Sleep Efficiency)
Time Frame: Day 1
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Pittsburgh sleep quality index (PSQI) Sleep efficiency (%) |
Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure
Time Frame: Day 1
|
Blood pressure using electronic devices that work on the oscillometric technique.
The systolic and diastolic blood pressure are both collected and reported
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Day 1
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Anthropometric Measurements 1
Time Frame: Day 1
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Height (kg)
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Day 1
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Anthropometric Measurements 2
Time Frame: Day 1
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Weight (kg)
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Day 1
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Anthropometric Measurements 3
Time Frame: Day 1
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Waist circumference (cm)
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Day 1
|
|
Skin Carotenoid Status
Time Frame: Day 1
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Measure with resonance Raman spectroscopy.
A higher score is indicative of raised skin carotenoid levels and hence, a better outcome
|
Day 1
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Perceived Stress Assessment
Time Frame: Day 1
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Perceived stress assessment (PSS) questionnaire Score: 0-40 (arbitrary unit; au) A higher score indicates higher perceived stress |
Day 1
|
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Blood Lipid and Glucose Profile
Time Frame: Day 1
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Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration
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Day 1
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Plasma Carotenoids Concentration
Time Frame: Day 1
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High performance liquid chromatography quantitative analyses of carotenoids in plasma samples
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jung Eun Kim, PhD, RD, NUS (Chemistry, FST)
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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