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

May 17, 2020 updated by: Jung Eun Kim, National University, Singapore
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 117599
        • Investigational Medical Unit (IMU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Sleep Quality Assessment 2
Time Frame: Day 1

Sleep evaluation questionnaire

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

Day 1
Dietary Assessment
Time Frame: Day 1
Food Frequency Questionnaire (FFQ)
Day 1
Dietary Assessment 2 (Dietary Carotenoids)
Time Frame: Day 3
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)
Time Frame: Day 1
Amino acid analysis on collected blood serum for blood amino acid profile.
Day 1
Dietary Assessment 2 (Dietary Macronutrients)
Time Frame: Day 3
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)
Time Frame: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep duration (hours)

Day 1
Sleep Quality Assessment 1 (Sleep Latency)
Time Frame: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep latency (minutes)

Day 1
Sleep Quality Assessment 1 (Sleep Efficiency)
Time Frame: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep efficiency (%)

Day 1

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
Day 1
Anthropometric Measurements 1
Time Frame: Day 1
Height (kg)
Day 1
Anthropometric Measurements 2
Time Frame: Day 1
Weight (kg)
Day 1
Anthropometric Measurements 3
Time Frame: Day 1
Waist circumference (cm)
Day 1
Skin Carotenoid Status
Time Frame: Day 1
Measure with resonance Raman spectroscopy. A higher score is indicative of raised skin carotenoid levels and hence, a better outcome
Day 1
Perceived Stress Assessment
Time Frame: Day 1

Perceived stress assessment (PSS) questionnaire

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

Day 1
Blood Lipid and Glucose Profile
Time Frame: Day 1
Plasma triglycerides, total cholesterol, ldl-cholesterol, hdl-cholesterol and glucose concentration
Day 1
Plasma Carotenoids Concentration
Time Frame: Day 1
High performance liquid chromatography quantitative analyses of carotenoids in plasma samples
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jung Eun Kim, PhD, RD, NUS (Chemistry, FST)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2018

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

April 22, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

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)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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