Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults. One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults. Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.
During the 16-week intervention, subjects will be randomly assigned to 1 of 3 groups including consuming normal-protein diet, higher-protein diet supplemented with micellar casein protein or higher-protein diet supplemented with soy protein. Recommended Dietary Allowances for healthy Singaporean. Normal-protein diet will be designed following a healthy eating pattern diet, referred to as the "My Healthy Plate" launched by Health Promotion Board and subjects will consume 3 servings of dietary protein. Higher-protein diet will also follow a healthy eating pattern diet while subjects will additionally take either 20 g micellar casein protein isolate or 20 g soy protein isolate. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff. Compliance with the diet interventions will be promoted by frequent online and in-person contact and dietary assessment. Blood amino acid concentration will also be assessed as an indicator of compliance to the protein intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
54
Intervention of the study include consuming a higher protein diet. Depending on the group allocation, this is done by asking the subjects to follow "My Healthy Plate" diet and consumption of 20g of protein isolates (casein or soy).
National University of Singapore
Singapore, Singapore
Change in sleep quality assessed by validated sleep questionnaires
Pittsburgh Sleep Quality Index Questionnaire (PSQI) will be used to assess the sleep quality. Overall score ranging from 0 to 21 points, where lower scores denote a healthier sleep quality.
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in sleep quality assessed by electronic equipment
An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in blood amino acid concentration
Amino acid concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in blood serotonin concentration
Serotonin concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration
6-sulfatoxymelatonin (aMT6s) concentration in the urine samples will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal microbiome composition
High-throughput sequencing method (using Illumina MiSeq platforms) will be used to assess the changes in gut microbiome composition
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal short chain fatty acid (SCFA) concentration
SCFA concentration in fecal samples will be measured.
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in serum lipopolysaccharide binding protein (LBP) concentration
LBP concentration in blood samples will be measured.
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in blood short chain fatty acid (SCFA) concentration
SCFA concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal bile acids
Bile acids concentration will be determined from fecal samples of the subjects
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal zonulin
Zonulin concentration will be determined from fecal samples of the subjects
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal calprotectin
Calprotectin concentration will be determined from fecal samples of the subjects
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in urinary creatinine concentration
Creatinine concentration in the urine samples will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Estimated Glomerular Filtration Rate (eGFR)
The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Trimethylamine N-oxide (TMAO)
Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Glucose
Glucose concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Triglyceride
Triglyceride concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Cholesterol
Total cholesterol concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Low-density Lipoprotein-cholesterol (LDL)
LDL concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood High-density Lipoprotein-cholesterol (LDL)
HDL concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Advanced Glycation End-product (AGEs)
AGEs concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Skin Advanced Glycation End-product (AGEs)
Using a scanner, the AGEs levels in the skin will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Interleukin-6 (IL-6)
Interleukin-6 (IL-6) concentration in the blood will be measured
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Endothelial Function
Endothelial functions are determined by the function of endothelial progenitor cells
Time frame: Baseline and Post-intervention (week 0 and week 16)
Change in Flow Mediate Dilation
Flow mediate dilation (%)
Time frame: Baseline and Post-intervention (week 0 and week 16)
Change in weight and height
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m\^2
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in waist circumference
Waist circumference (in cm) will be measured
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in blood pressure
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Dietary assessment
Dietary assessment will be assessed by 3-day dietary food record
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (stress)
Perceived Stress Scale (PSS) will be used to assess the stress levels
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (depression)
Geriatric Depression Scale (GDS) Assessment will be used to assess the depression status
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (anxiety)
Geriatric Anxiety Inventory (GAI) Assessment will be used to assess the anxiety status.
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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