Pre-sleep Macros on Sleep Quality and Recovery

Sponsor

Florida State University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06102460

Collaborator

Milk Specialties Global (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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:

Casein Protein
a-lactalbumin Protein
Carbohydrate
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.

Condition or Disease	Intervention/Treatment	Phase
Sleep	Dietary Supplement: Casein protein Dietary Supplement: a-lactalbumin protein Dietary Supplement: Carbohydrate Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

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.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Sports Sciences and Medicine - Florida State University	Tallahassee	Florida	United States	32303

Sponsors and Collaborators

Florida State University
Milk Specialties Global

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael J. Ormsbee, Director, Florida State University

ClinicalTrials.gov Identifier:

NCT06102460

Other Study ID Numbers:

STUDY00004409

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Caseins

Study Results

No Results Posted as of Oct 26, 2023