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Clinical Trials/NCT06102460
NCT06102460CompletedNot Applicable

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

Florida State University2 sites in 1 country20 target enrollmentStarted: January 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Recovery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts 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.

Outcomes

Primary Outcomes

Recovery

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

Recovery score determined by WHOOP 4.0 wearable device

Sleep

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

Sleep score determined by WHOOP 4.0 wearable device

Secondary Outcomes

  • Subjective recovery score(Data obtained 1-2 hours after after subject awakes)
  • Blood glucose control(Continuous (24hours/day) during intervention days/nights)
  • Subjective sleep score(Data obtained 1-2 hours after after subject awakes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael J. Ormsbee

Director

Florida State University

Study Sites (2)

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