Trial Outcomes & Findings for Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population (NCT NCT03554954)

NCT ID: NCT03554954

Last Updated: 2020-06-01

Results Overview

Pittsburgh sleep quality index (PSQI) Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality

• Recruitment status: COMPLETED
• Target enrollment: 108 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2020-06-01

Participant Flow

Participant milestones

Measure	Food/Nutrient Intake and Sleep Quality Cross-sectional research design: * fasting-state blood data (plasma amino acids) * general health assessment (e.g. blood pressure, anthropometric measurement) * dietary data * stress and sleep quality assessment
Overall Study STARTED	108
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Association Between Food/Nutrient Intake and Sleep Quality n=108 Participants This is a cross-sectional study and it does not have an arm/group
Age, Continuous	58.8 years STANDARD_DEVIATION 5.9 • n=93 Participants
Sex: Female, Male Female	62 Participants n=93 Participants
Sex: Female, Male Male	46 Participants n=93 Participants
Race/Ethnicity, Customized Race · Chinese	94 Participants n=93 Participants
Race/Ethnicity, Customized Race · Caucasian	4 Participants n=93 Participants
Race/Ethnicity, Customized Race · Malaysian	3 Participants n=93 Participants
Race/Ethnicity, Customized Race · Indian	6 Participants n=93 Participants
Race/Ethnicity, Customized Race · Others	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 1

Pittsburgh sleep quality index (PSQI)

Global Sleep Score (GSS): 0-21 (arbitrary unit; au) A lower value indicates better sleep quality

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Sleep Quality Assessment 1 (GSS)	3.4 score on a scale Standard Deviation 1.3	8.1 score on a scale Standard Deviation 1.9	5.2 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Day 1

Sleep evaluation questionnaire

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Sleep Quality Assessment 2	5.54 score on a scale Standard Deviation 2.32	9.08 score on a scale Standard Deviation 3.69	6.87 score on a scale Standard Deviation 3.37

PRIMARY outcome

Timeframe: Day 1

Food Frequency Questionnaire (FFQ)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Dietary Assessment 2 (Dietary Carotenoids)	11.6 mg Standard Deviation 8.8	8.8 mg Standard Deviation 6.7	10.5 mg Standard Deviation 8.1

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Blood Amino Acid Concentration (Plasma Tryptophan)	21.6 nmol/mL Standard Deviation 9.2	24.7 nmol/mL Standard Deviation 11.3	22.8 nmol/mL Standard Deviation 10.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Dietary Assessment 2 (Dietary Macronutrients) Total Fat	34.3 percentage of energy intake Standard Deviation 6.4	32.8 percentage of energy intake Standard Deviation 7	33.7 percentage of energy intake Standard Deviation 6.6
Dietary Assessment 2 (Dietary Macronutrients) Total Carbohydrate	47.3 percentage of energy intake Standard Deviation 6.8	48.1 percentage of energy intake Standard Deviation 8.7	47.6 percentage of energy intake Standard Deviation 7.5
Dietary Assessment 2 (Dietary Macronutrients) Total Protein	18.4 percentage of energy intake Standard Deviation 4.0	19.1 percentage of energy intake Standard Deviation 4.2	18.7 percentage of energy intake Standard Deviation 4.1

PRIMARY outcome

Timeframe: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep duration (hours)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Sleep Quality Assessment 1 (Sleep Duration)	6.7 hours Standard Deviation 1.1	6.2 hours Standard Deviation 1.3	6.5 hours Standard Deviation 1.2

PRIMARY outcome

Timeframe: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep latency (minutes)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Sleep Quality Assessment 1 (Sleep Latency)	10 minutes Standard Deviation 7.6	26 minutes Standard Deviation 17.7	16.0 minutes Standard Deviation 14.5

PRIMARY outcome

Timeframe: Day 1

Pittsburgh sleep quality index (PSQI)

Sleep efficiency (%)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Sleep Quality Assessment 1 (Sleep Efficiency)	93.9 percentage of sleep from time in bed Standard Deviation 5.8	84.6 percentage of sleep from time in bed Standard Deviation 9.7	90.4 percentage of sleep from time in bed Standard Deviation 8.7

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Blood Pressure Systolic Blood Pressure	118.9 mmHg Standard Deviation 16.1	113.4 mmHg Standard Deviation 18.4	116.8 mmHg Standard Deviation 17.1
Blood Pressure Diastolic Blood Pressure	76 mmHg Standard Deviation 10.2	73.1 mmHg Standard Deviation 11.3	74.9 mmHg Standard Deviation 10.7

SECONDARY outcome

Timeframe: Day 1

Height (kg)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Anthropometric Measurements 1	161.9 cm Standard Deviation 7.9	160.2 cm Standard Deviation 8.9	161.3 cm Standard Deviation 8.3

SECONDARY outcome

Timeframe: Day 1

Weight (kg)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Anthropometric Measurements 2	63.2 kg Standard Deviation 14.0	60.7 kg Standard Deviation 11.6	62.3 kg Standard Deviation 13.1

SECONDARY outcome

Timeframe: Day 1

Waist circumference (cm)

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Anthropometric Measurements 3	83.6 cm Standard Deviation 13.1	81.5 cm Standard Deviation 10.3	82.8 cm Standard Deviation 12.1

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Skin Carotenoid Status	32746 score on a scale Standard Deviation 11195	35307 score on a scale Standard Deviation 13139	33707 score on a scale Standard Deviation 11963

SECONDARY outcome

Timeframe: Day 1

Population: Current data is the overall mean of the subjects that has participated. Comparison analysis is incomplete and still in progress.

Perceived stress assessment (PSS) questionnaire

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Perceived Stress Assessment	10.5 score on a scale Standard Deviation 5.3	14.8 score on a scale Standard Deviation 5.8	12.1 score on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Blood Lipid and Glucose Profile Triglyceride	1.23 mmol/L Standard Deviation 0.57	1.16 mmol/L Standard Deviation 0.54	1.20 mmol/L Standard Deviation 0.56
Blood Lipid and Glucose Profile Total cholesterol	5.4 mmol/L Standard Deviation 1.0	5.3 mmol/L Standard Deviation 1.0	5.3 mmol/L Standard Deviation 1.0
Blood Lipid and Glucose Profile LDL-cholesterol	3.22 mmol/L Standard Deviation 0.88	3.15 mmol/L Standard Deviation 0.94	3.19 mmol/L Standard Deviation 0.90
Blood Lipid and Glucose Profile HDL-cholesterol	1.58 mmol/L Standard Deviation 0.48	1.62 mmol/L Standard Deviation 0.45	1.60 mmol/L Standard Deviation 0.47
Blood Lipid and Glucose Profile Glucose	5.50 mmol/L Standard Deviation 0.89	5.37 mmol/L Standard Deviation 1.26	5.5 mmol/L Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 1

High performance liquid chromatography quantitative analyses of carotenoids in plasma samples

Outcome measures

Measure	Good Sleep Quality n=65 Participants GSS\<=5	Poor Sleep Quality n=39 Participants GSS\>5	Overall Data n=104 Participants Overall subject data
Plasma Carotenoids Concentration	1.14 mg/L Standard Deviation 0.51	1.22 mg/L Standard Deviation 0.76	1.17 mg/L Standard Deviation 0.61

Adverse Events

Association Between Food/Nutrient Intake and Sleep Quality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kim Jung Eun

National University of Singapore

Phone: 65161136

Email: fstkje@nus.edu.sg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place