Pre-sleep Macros on Sleep Quality and Recovery

NCT ID: NCT06102460

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-03-15

Brief Summary

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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

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Neither the participant or investigator will know what treatment has been given until un-blinding at the completion of the study.

Study Groups

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Casein Protein

Each participant will consume a serving of casein protein mix.

Group Type ACTIVE_COMPARATOR

Casein protein

Intervention Type DIETARY_SUPPLEMENT

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

a-lactalbumin

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

Group Type ACTIVE_COMPARATOR

a-lactalbumin protein

Intervention Type DIETARY_SUPPLEMENT

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

Carbohydrate

Each participant will consume a serving of carbohydrate mix.

Group Type ACTIVE_COMPARATOR

Carbohydrate

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Each participant will consume a serving of a placebo mix.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Casein protein

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

Intervention Type DIETARY_SUPPLEMENT

a-lactalbumin protein

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

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Milk Specialties Global

INDUSTRY

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Ormsbee

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Sports Sciences and Medicine - Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004409

Identifier Type: -

Identifier Source: org_study_id

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