SleepNCT06102460
Pre-sleep Macros on Sleep Quality and Recovery
A study testing Casein protein, a-lactalbumin protein and Carbohydrate in people with Sleep, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Sleep
- What is being tested?
- Casein protein, a-lactalbumin protein and Carbohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- NCAA Division I female athlete
- Wearing WHOOP 4.0 device for >3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Sports Sciences and Medicine - Florida State University
Tallahassee, Florida, 32303
About this study
Official title: The Effect of Pre-sleep Milk-derived Protein to Support Sleep Quality and Recovery in Elite Female Athletes
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:
Read more
- 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.
- Conditions
- Sleep
- Being tested
- Casein protein, a-lactalbumin protein, Carbohydrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein proteinDietary supplement
40 grams of casein protein powder mixed with 8-10 fl. oz. of water.
a-lactalbumin proteinDietary supplement
40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water.
CarbohydrateDietary supplement
40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water.
PlaceboDietary supplement
Zero calorie, placebo powder mixed with 8-10 fl. oz. of water.
| Study group | Role | What they receive |
|---|---|---|
| Casein Protein | Active comparator | Each participant will consume a serving of casein protein mix. Receives: Dietary Supplement: Casein protein |
| a-lactalbumin | Active comparator | Each participant will consume a serving of a-lactalbumin protein mix. Receives: Dietary Supplement: a-lactalbumin protein |
| Carbohydrate | Active comparator | Each participant will consume a serving of carbohydrate mix. Receives: Dietary Supplement: Carbohydrate |
| Placebo | Placebo comparator | Each participant will consume a serving of a placebo mix. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Sleep score determined by WHOOP 4.0 wearable device
Measured: Data obtained from device 12 hours after ingestion of supplement
Recovery
Recovery score determined by WHOOP 4.0 wearable device
Measured: Data obtained from device 12 hours after ingestion of supplement
Secondary outcomes (3)
Subjective sleep score
Subjective sleep score obtained from questionnaire
Measured: Data obtained 1-2 hours after after subject awakes
Subjective recovery score
Subjective sleep score obtained from questionnaire
Measured: Data obtained 1-2 hours after after subject awakes
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.
Measured: Continuous (24hours/day) during intervention days/nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start23 Jan 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all 4 interventions with at least a 1 week wash out period in between.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Milk Specialties Global
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102460
- Sponsor's protocol ID
- STUDY00004409
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-sleep Milk-derived Protein to Support Sleep Quality and Recovery in Elite Female Athletes
- ClinicalTrials.gov ID
- NCT06102460
- Acronym / sponsor ID
- STUDY00004409
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Milk Specialties Global
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- All participants will complete all 4 interventions with at least a 1 week wash out period in between.
| Arm | Type | Receives |
|---|---|---|
| Casein Protein | Active comparator | Dietary Supplement: Casein proteinEach participant will consume a serving of casein protein mix. |
| a-lactalbumin | Active comparator | Dietary Supplement: a-lactalbumin proteinEach participant will consume a serving of a-lactalbumin protein mix. |
| Carbohydrate | Active comparator | Dietary Supplement: CarbohydrateEach participant will consume a serving of carbohydrate mix. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach participant will consume a serving of a placebo mix. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- NCAA Division I female athlete
- Wearing WHOOP 4.0 device for >3 months
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casein protein40 grams of casein protein powder mixed with 8-10 fl. oz. of water. | Dietary supplement | Casein Protein |
| a-lactalbumin protein40 grams of a-lactalbumin protein powder mixed with 8-10 fl. oz. of water. | Dietary supplement | a-lactalbumin |
| Carbohydrate40 grams of a carbohydrate powder mixed with 8-10 fl. oz. of water. | Dietary supplement | Carbohydrate |
| PlaceboZero calorie, placebo powder mixed with 8-10 fl. oz. of water. | Dietary supplement | Placebo |
Primary outcome
Sleep
Time frame: Data obtained from device 12 hours after ingestion of supplement
Sleep score determined by WHOOP 4.0 wearable device
Recovery
Time frame: Data obtained from device 12 hours after ingestion of supplement
Recovery score determined by WHOOP 4.0 wearable device
3 secondary outcomes
Subjective sleep score
Time frame: Data obtained 1-2 hours after after subject awakes
Subjective recovery score
Time frame: Data obtained 1-2 hours after after subject awakes
Blood glucose control
Time frame: Continuous (24hours/day) during intervention days/nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein protein, a-lactalbumin protein and Carbohydrate in people with Sleep, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: Data obtained from device 12 hours after ingestion of supplement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.