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Pre-sleep Macros on Sleep Quality and Recovery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06102460
Enrollment
20
Registered
2023-10-26
Start date
2024-01-23
Completion date
2025-03-15
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Brief 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.

Interventions

DIETARY_SUPPLEMENTCasein protein

40 grams of casein protein powder mixed with 8-10 fl. oz. of water.

DIETARY_SUPPLEMENTa-lactalbumin protein

40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.

DIETARY_SUPPLEMENTCarbohydrate

40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.

DIETARY_SUPPLEMENTPlacebo

Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.

Sponsors

Milk Specialties Global
CollaboratorINDUSTRY
Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

Neither the participant or investigator will know what treatment has been given until un-blinding at the completion of the study.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SleepData obtained from device 12 hours after ingestion of supplementSleep score determined by WHOOP 4.0 wearable device
RecoveryData obtained from device 12 hours after ingestion of supplementRecovery score determined by WHOOP 4.0 wearable device

Secondary

MeasureTime frameDescription
Subjective sleep scoreData obtained 1-2 hours after after subject awakesSubjective sleep score obtained from questionnaire
Subjective recovery scoreData obtained 1-2 hours after after subject awakesSubjective sleep score obtained from questionnaire
Blood glucose controlContinuous (24hours/day) during intervention days/nightsUsing the continuous glucose monitor, participants blood glucose response throughout the day and night relative to regular meals and intervention will be observed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026