Pre-sleep Macros on Sleep Quality and Recovery

NCT06102460 | Completed

• 1 other identifier: STUDY00004409
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Casein Protein
2. 2.a-lactalbumin Protein
3. 3.Carbohydrate
4. 4.Placebo

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• Sleep

  Sleep score determined by WHOOP 4.0 wearable device

  Data obtained from device 12 hours after ingestion of supplement

• Recovery

  Recovery score determined by WHOOP 4.0 wearable device

  Data obtained from device 12 hours after ingestion of supplement

Secondary Outcomes (3)

• Subjective sleep score

  Data obtained 1-2 hours after after subject awakes

• Subjective recovery score

  Data obtained 1-2 hours after after subject awakes

• Blood glucose control

  Continuous (24hours/day) during intervention days/nights

Study Arms (4)

Casein Protein

ACTIVE COMPARATOR

Each participant will consume a serving of casein protein mix.

Dietary Supplement: Casein protein

a-lactalbumin

ACTIVE COMPARATOR

Each participant will consume a serving of a-lactalbumin protein mix.

Dietary Supplement: a-lactalbumin protein

Carbohydrate

ACTIVE COMPARATOR

Each participant will consume a serving of carbohydrate mix.

Dietary Supplement: Carbohydrate

Placebo

PLACEBO COMPARATOR

Each participant will consume a serving of a placebo mix.

Dietary Supplement: Placebo

Interventions

Casein protein DIETARY_SUPPLEMENT

40 grams of casein protein powder mixed with 8-10 fl. oz. of water.

Casein Protein

a-lactalbumin protein DIETARY_SUPPLEMENT

40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.

a-lactalbumin

Carbohydrate DIETARY_SUPPLEMENT

40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.

Carbohydrate

Placebo DIETARY_SUPPLEMENT

Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• NCAA Division I female athlete
• Wearing WHOOP 4.0 device for \>3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Milk Specialties Global: collaborator

Study Sites (1)

Institute of Sports Sciences and Medicine - Florida State University

Tallahassee, Florida, 32303, United States

Location

MeSH Terms

Interventions

Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participant or investigator will know what treatment has been given until un-blinding at the completion of the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

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

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 26, 2023
• Study Start: January 23, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)