Pre-sleep Macros on Sleep Quality and Recovery

NCT06102460 — Not applicable, Completed, 20 participants, Florida State University

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

Registry	NCT06102460
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, other
Enrollment	20 (Actual)
Sponsor	Florida State University (Other); collaborators: Milk Specialties Global
Conditions	Sleep
Interventions	Casein protein, a-lactalbumin protein, Carbohydrate, Placebo (Dietary supplement)
Dates	start 2024-01-23, primary completion 2025-03-15, completion 2025-03-15, first posted 2023-10-26, last updated 2025-03-25
Locations	1 site in United States

-Summary

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:

1. Casein Protein
2. a-lactalbumin Protein
3. Carbohydrate
4. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Casein Protein	Active comparator	Dietary Supplement: Casein protein	Each participant will consume a serving of casein protein mix.
a-lactalbumin	Active comparator	Dietary Supplement: a-lactalbumin protein	Each participant will consume a serving of a-lactalbumin protein mix.
Carbohydrate	Active comparator	Dietary Supplement: Carbohydrate	Each participant will consume a serving of carbohydrate mix.
Placebo	Placebo comparator	Dietary Supplement: Placebo	Each participant will consume a serving of a placebo mix.

Casein protein (Dietary supplement): 40 grams of casein protein powder mixed with 8-10 fl. oz. of water.
a-lactalbumin protein (Dietary supplement): 40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.
Carbohydrate (Dietary supplement): 40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.
Placebo (Dietary supplement): Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.

+Outcome measures

Primary outcomes

Sleep [Data obtained from device 12 hours after ingestion of supplement]: Sleep score determined by WHOOP 4.0 wearable device
Recovery [Data obtained from device 12 hours after ingestion of supplement]: Recovery score determined by WHOOP 4.0 wearable device

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 25 Years

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.

+Locations (1)

Facility	City	Country	Status
Institute of Sports Sciences and Medicine - Florida State University	Tallahassee, Florida	United States

My Notes

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