Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits

Conditions
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Sleep

Intervention / Treatment
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* Other: Test Product
* Other: Control Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able provide written informed consent (in English) Aged 25-50 BMI range from 18.5 to 24.9 kg/m2 Subjective sleep complaints (PSQI > 5) Exclusion Criteria: Diagnosed food allergy or other intolerance to the investigational products, control products and standardized meals Significant past medical and psychiatric history and ongoing chronic conditions for example cardiovascular disease, respiratory disease, metabolic disorder, endocrine disorder (e.g. diabetes mellitus, history of hypoglycemia), and neurological and psychiatric conditions, and conditions that the investigator deem inappropriate to enter the clinical trials Significant medication history including use of corticosteroid in oral or systemic format and antidepressants (e.g. Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors) Pregnant or intending to conceive during the course of clinical trial and up to one month after trial conclusion, or not able to comply with a highly effective form of birth control or lactating during the clinical trial. Highly effective contraception includes hormonal methods, such as the contraceptive pill or implant, or an intrauterine device (IUD), or barrier methods such as diaphragm plus spermicide or condom plus spermicide. Pregnancy status will be assessed using urinary dipsticks at the beginning and end of the study period (V0 and V9). Parents of children less than 12 months of age, which is a known factor of sleep disturbances. Peri- and post-menopausal women Known or diagnosed sleep disorders Special diets, including for instance halal food preference, vegetarian, high protein or weight loss program, and diets with either too low (< 35% daily energy from CHO; e.g., ketogenic diet, Atkins diet, zero-carb diet, low-carb paleo/Mediterranean diet, carb cycling diet) or too high carbohydrate (>70% daily energy from CHO) content . Chronic exercisers, defined as subjects exercising > 1 h/day for at least 5 days/week Caffeine consumption over the recommended daily limit (above 400 mg; equivalent to approximately 4-5 cups of coffee) Substance abuse including over the limit alcohol consumption (2 standard drinks/day for males, 1 standard drink/day for female) Cigarette and Tobacco Smokers Intake of dietary supplements that may affect sleep conditions (e.g. melatonin, theanine, tryptophan, GABA, magnesium, zinc) Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol. Participating in other clinical trials or had been participating in other clinical trial in the preceding 1 month. Subjects belonging to a household where at least one other person is taking part in the trial.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test - Control product<br>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). | Other: Test Product<br>* Whey Protein Isolate with Mulberry leaf extract<br>Other: Control Product<br>* Wheat Protein Hydrolysate<br>|
| Experimental: Control - Test product<br>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). | Other: Test Product<br>* Whey Protein Isolate with Mulberry leaf extract<br>Other: Control Product<br>* Wheat Protein Hydrolysate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective sleep complaints