Pre-sleep Macros on Sleep Quality and Recovery

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06102460
• Other study ID #: STUDY00004409
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Casein protein
40 grams of casein protein powder mixed with 8-10 fl. oz. of water.
• a-lactalbumin protein
40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.
• Carbohydrate
40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.
• Placebo
Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.

Locations

Country	Name	City	State
United States	Institute of Sports Sciences and Medicine - Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Milk Specialties Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Sleep score determined by WHOOP 4.0 wearable device	Data obtained from device 12 hours after ingestion of supplement
Primary	Recovery	Recovery score determined by WHOOP 4.0 wearable device	Data obtained from device 12 hours after ingestion of supplement
Secondary	Subjective sleep score	Subjective sleep score obtained from questionnaire	Data obtained 1-2 hours after after subject awakes
Secondary	Subjective recovery score	Subjective sleep score obtained from questionnaire	Data obtained 1-2 hours after after subject awakes
Secondary	Blood glucose control	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