Pre-sleep Macros on Sleep Quality and Recovery

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the effect of eating before bed (2 hours after dinner, 30mins before bed) and the effects this has on sleep and recovery measures in elite female athletes. Participants will be randomized to 4 possible groups in a double-blind randomized cross over design. Each group will ingest 40 grams of one of the following nutrients as a liquid shake for 3 consecutive nights: Casein Protein a-lactalbumin Protein Carbohydrate Placebo There will be at least 1 week washout period between each intervention. Sleep and recovery outcome measures will be obtained through a WHOOP 4.0 wearable healthy tracking device. Subjective sleep and recovery will be obtained through subjective questionnaires. Food will be logged by participants on intervention days. Blood glucose will be measured using continuous glucose monitors.

Official Title
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The Effect of Pre-sleep Milk-derived Protein to Support Sleep Quality and Recovery in Elite Female Athletes

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Casein protein
* Dietary Supplement: a-lactalbumin protein
* Dietary Supplement: Carbohydrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NCAA Division I female athlete Wearing WHOOP 4.0 device for >3 months Exclusion Criteria: Musculoskeletal injuries limiting participation in regular team practice. Cardiometabolic diseases limiting participation in regular team practice. Pre-diagnosed sleep condition that would negatively affect sleep quality or quantity (sleep apnea, restless leg syndrome, night-feeding syndrome) Allergy to any dietary supplement used in protocol - e.g., lactose intolerant. Use of sleep aids such as but not limited to, melatonin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: All participants will complete all 4 interventions with at least a 1 week wash out period in between.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Casein Protein<br>Each participant will consume a serving of casein protein mix. | Dietary Supplement: Casein protein<br>* 40 grams of casein protein powder mixed with 8-10 fl. oz. of water.<br>|
| Active Comparator: a-lactalbumin<br>Each participant will consume a serving of a-lactalbumin protein mix. | Dietary Supplement: a-lactalbumin protein<br>* 40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.<br>|
| Active Comparator: Carbohydrate<br>Each participant will consume a serving of carbohydrate mix. | Dietary Supplement: Carbohydrate<br>* 40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.<br>|
| Placebo Comparator: Placebo<br>Each participant will consume a serving of a placebo mix. | Dietary Supplement: Placebo<br>* Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Sleep score determined by WHOOP 4.0 wearable device | Data obtained from device 12 hours after ingestion of supplement | 
| Recovery | Recovery score determined by WHOOP 4.0 wearable device | Data obtained from device 12 hours after ingestion of supplement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep score | Subjective sleep score obtained from questionnaire | Data obtained 1-2 hours after after subject awakes | 
| Subjective recovery score | Subjective sleep score obtained from questionnaire | Data obtained 1-2 hours after after subject awakes | 
| Blood glucose control | Using the continuous glucose monitor, participants blood glucose response throughout the day and night relative to regular meals and intervention will be observed. | Continuous (24hours/day) during intervention days/nights |