The study aim to test the effect of a meal complement to be taken in combination with an evening meal with a glycemic load of 55, to improve sleep quality.
Considering emerging evidence on the role of the macro and micro-nutrient composition of evening meals, the intervention used in this study will be designed to provide the necessary nutrients to promote sleep quality. The IP will be a low caloric nutritional solution, combining: * Ingredients lowering glycemic response to evening meals to promote sleep quality * a protein source rich in bioavailable tryptophan to promote sleep quality * supporting ingredients contributing to sleep initiation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
43
Whey Protein Isolate with Mulberry leaf extract
Wheat Protein Hydrolysate
Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine
Singapore, Singapore
Changes in sleep efficiency (actigraphy)
Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good.
Time frame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Change in sleep latency (actigraphy)
Measured as the amount of time it takes subjects to fall asleep after going to bed (in minutes)
Time frame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Changes in self-reported sleep quality via Actigraphy
Changes in WASO \& total sleep duration
Time frame: Day 1 (V1) to Day 15 (V2) , Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Changes in self-reported sleep quality via KSD
Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (KSD)
Time frame: Day 1 (V1), Day 15 (V2), Day 22 (V3), Day 23, Day 24 (V4) to Day 37, Day 45 and 65, Day 66 (V7) to Day 79, Day 87 (V9)
Changes in self-reported sleep quality via ESS
Changes in self-reported sleep quality measured through questionnaire Epworth Sleepiness Scale (ESS)
Time frame: Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)
Glycemia
Glycemia measured by continuous glucose monitoring: * Glucose response of the evening standard meal with the test product or the control product * Glucose excursion during the night (from time to bed to wakening) * Subsequent breakfast
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79
Mood states, alertness, and sleepiness via BMIS
Questionnaire Brief Mood Introspection Scale (BMIS)
Time frame: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Mood states, alertness, and sleepiness via KSS
Questionnaire Karolinska Sleepiness Scale (KSS)
Time frame: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Mood states, alertness, and sleepiness via POMS-SF 2
Questionnaire Profile of Mood States - Short Form 2 (POMS-SF 2)
Time frame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition tasks via Immediate & delayed free recall
Immediate \& delayed free recall
Time frame: Day 22 (V3), Day 23, 37, 65, 79
Cognition task PVT
Psychomotor Vigilance Task (PVT)
Time frame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition test N-back task
N-back task
Time frame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition test Go/No-Go task
Go/No-Go task
Time frame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition task NASA-TLX
NASA task load index (NASA-TLX)
Time frame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79