Pre-sleep Macros on Sleep Quality and Recovery

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Dietary Supplement: Casein protein; Dietary Supplement: Placebo; Dietary Supplement: Carbohydrate; Dietary Supplement: a-lactalbumin protein

• Registration Number: NCT06102460
• Lead Sponsor: Florida State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Study Start: 2024-01-23
• Status Verified: 2025-03
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Casein Protein	Casein protein	Each participant will consume a serving of casein protein mix.
Placebo	Placebo	Each participant will consume a serving of a placebo mix.
Carbohydrate	Carbohydrate	Each participant will consume a serving of carbohydrate mix.
a-lactalbumin	a-lactalbumin protein	Each participant will consume a serving of a-lactalbumin protein mix.

Primary Outcome Measures

Name	Time	Method
Recovery	Data obtained from device 12 hours after ingestion of supplement	Recovery score determined by WHOOP 4.0 wearable device
Sleep	Data obtained from device 12 hours after ingestion of supplement	Sleep score determined by WHOOP 4.0 wearable device

Secondary Outcome Measures

Name	Time	Method
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.
Subjective sleep score	Data obtained 1-2 hours after after subject awakes	Subjective sleep score obtained from questionnaire

Trial Locations

Locations (1)

Institute of Sports Sciences and Medicine - Florida State University; 🇺🇸 Tallahassee, Florida, United States