Pre-sleep Macros on Sleep Quality and Recovery

January 29, 2024 updated by: Michael J. Ormsbee, Florida State University

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32303
        • Institute of Sports Sciences and Medicine - Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: Data obtained from device 12 hours after ingestion of supplement
Sleep score determined by WHOOP 4.0 wearable device
Data obtained from device 12 hours after ingestion of supplement
Recovery
Time Frame: Data obtained from device 12 hours after ingestion of supplement
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
Time Frame: Data obtained 1-2 hours after after subject awakes
Subjective sleep score obtained from questionnaire
Data obtained 1-2 hours after after subject awakes
Subjective recovery score
Time Frame: Data obtained 1-2 hours after after subject awakes
Subjective sleep score obtained from questionnaire
Data obtained 1-2 hours after after subject awakes
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.
Continuous (24hours/day) during intervention days/nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

Milk Specialties Global

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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