Status:
ACTIVE_NOT_RECRUITING
Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults
Lead Sponsor:
National University of Singapore
Conditions:
Sleep
Gut Microbiome
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
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 increas...
Detailed Description
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-pr...
Eligibility Criteria
Inclusion
- Adults 60-85 years old
- Not following HPB diet
Exclusion
- Weight change \> 3kg in the past 3 months
- Exercise vigorously over the past 3 months
- Drinking more than 2 alcoholic drinks per day
- (if applicable) Pre-menopausal women
- Taking dietary supplements or medications which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), Trp, 5-HTP or melatonin supplementations) the past 1 month
- Taking dietary supplements which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics) the past 2 months (a list of fermented foods)
- Impaired renal function (normal values: estimated glomerular filtration rate ≥ 90 mL/min/1.73 m2 calculated by chronic kidney disease epidemiology collaboration equation; CKD EPI)
- Soy intolerance and/or allergy or any medical conditions that may be affected by consumption of soy products (e.g. gout)
- Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication or Chinese medicine herb which started less than 3 years prior to the intervention participation
- Diagnosed with gut/gastrointestinal issues such as lactose intolerance and irritable bowel syndrome (IBS)
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05400005
Start Date
February 1 2023
End Date
December 1 2025
Last Update
September 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National University of Singapore
Singapore, Singapore, 117546