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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test - Control product | Experimental | Subject will start with consuming the test product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the control product daily for total 14 days (during intervention period 2). |
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| Control - Test product | Experimental | Subject will start with consuming the control product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the test product daily for total 14 days (during intervention period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product | Other | Whey Protein Isolate with Mulberry leaf extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep efficiency (actigraphy) | Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good. | 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in self-reported sleep quality via Actigraphy | Changes in WASO & total sleep duration | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol levels in the morning | Cortisol levels in saliva as an objective index of stress | Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8) |
| Melatonin synthesis marker (6-sulfatoxymelatonin) | 6-sulfatoxymelatonin levels in urine as an index of melatonin synthesis, which will be reported as a ratio of urinary 6-sulfatoxymelatonin to urinary creatinine. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Chee | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine | Singapore | 117549 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40072601 | Derived | Soon CS, Thota R, Owen L, Tian L, Martin FP, Mantantzis K, Cherta-Murillo A, Campos VC, Chkroun C, Lavalle L, Hartweg M, St-Onge MP, Chee MWL, Darimont C. Mulberry leaf extract combined with tryptophan improves sleep and post wake mood in adults with sleep complaints - A randomized cross-over study. Eur J Nutr. 2025 Mar 12;64(3):124. doi: 10.1007/s00394-025-03643-8. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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This is a double-blind, controlled, randomized, 2-arm, cross-over, group sequential design clinical trial. Subjects will receive the two different interventions in a randomized order.
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| Control Product | Other | Wheat Protein Hydrolysate |
|
Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (KSD) |
| 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) | Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87) |
| Glycemia | Glycemia measured by continuous glucose monitoring:
| 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) | 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) | 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) | Day 22 (V3), Day 23, 31, 37, 65, 73, 79 |
| Cognition tasks via Immediate & delayed free recall | Immediate & delayed free recall | Day 22 (V3), Day 23, 37, 65, 79 |
| Cognition task PVT | Psychomotor Vigilance Task (PVT) | Day 22 (V3), Day 23, 31, 37, 65, 73, 79 |
| Cognition test N-back task | N-back task | Day 22 (V3), Day 23, 31, 37, 65, 73, 79 |
| Cognition test Go/No-Go task | Go/No-Go task | Day 22 (V3), Day 23, 31, 37, 65, 73, 79 |
| Cognition task NASA-TLX | NASA task load index (NASA-TLX) | Day 22 (V3), Day 23, 31, 37, 65, 73, 79 |
| Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8) |
| Assess effect of sleep hygiene behaviors and life events on sleep patterns | Sleep hygiene questionnaire | Visit 0 (pre Day1), Day 23, Day 65 |
| Change in sleep efficiency, calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good | Measure of sleep parameter using the commercial sensor Oura ring | 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 (mins), measured in time needed to fall asleep after going to bed. | Measure of sleep parameter using the commercial sensor Oura ring | 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 WASO (actigraphy) - proportion of people reaching < 30 mins | Measure of sleep parameter using the commercial sensor Oura ring | 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 total sleep duration (mins; actigraphy) | Measure of sleep parameter using the commercial sensor Oura ring. | 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) |
| D008722 | Methods |