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OpenTrials
Completed

NCT Number: NCT06102460

Pre-sleep Macros on Sleep Quality and Recovery

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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Key information

Conditions

Sleep

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Sciences and Medicine - Florida State University

Tallahassee, Florida, 32303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sleep

    Time frame: Data obtained from device 12 hours after ingestion of supplement

    Sleep score determined by WHOOP 4.0 wearable device

  2. Recovery

    Time frame: Data obtained from device 12 hours after ingestion of supplement

    Recovery score determined by WHOOP 4.0 wearable device

Secondary outcomes

  1. Subjective sleep score

    Time frame: Data obtained 1-2 hours after after subject awakes

    Subjective sleep score obtained from questionnaire

  2. Subjective recovery score

    Time frame: Data obtained 1-2 hours after after subject awakes

    Subjective sleep score obtained from questionnaire

  3. Blood glucose control

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Milk Specialties Global

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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