Pre-sleep Nutrients for Sleep Quality

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Sleep aids

Disqualifiers: Musculoskeletal, Cardiometabolic, Sleep conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 nights per intervention with at least 1 week washout period between each

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nutrients consumed before bed affect sleep and recovery in elite female athletes. Researchers will divide participants into four groups to test casein protein, a-lactalbumin protein, carbohydrates, or a placebo. Each participant will try all options at different times, with breaks in between. Ideal candidates are NCAA Division I female athletes who have used a WHOOP 4.0 device for more than three months. As an unphased trial, this study offers a unique opportunity to contribute to understanding nutrition's impact on athletic performance and recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use sleep aids like melatonin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the nutrients tested in this trial—casein protein, a-lactalbumin protein, and carbohydrates—are generally safe and well-tolerated. Studies have found that consuming 40 grams of casein protein before bed does not harm sleep quality or next-day performance. It also aids muscle growth and recovery overnight.

Research on a-lactalbumin protein suggests it can enhance sleep quality and morning alertness, particularly for those with sleep issues. It may also increase serotonin levels, aiding sleep.

Carbohydrate consumption has been linked to faster sleep onset, especially with high-glycemic index (GI) meals, and can improve sleep stages. However, excessive intake of low-quality carbs might negatively affect sleep.

Overall, these nutrients have been studied and show promising safety for improving sleep and recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore how different pre-sleep nutrients might enhance sleep quality. Unlike typical sleep aids, which often include medications like melatonin or sedatives, this study investigates the effects of a-lactalbumin protein, casein protein, and carbohydrates. These nutrients might improve sleep by naturally influencing the body's amino acids and serotonin production, potentially leading to better sleep patterns without the side effects associated with traditional sleep medications. This approach could offer a more holistic and gentle method for improving sleep, appealing to those looking for natural alternatives.

What evidence suggests that this trial's treatments could be effective for improving sleep quality in elite female athletes?

Research has shown that consuming a-lactalbumin protein before bed might improve sleep quality, particularly for those who struggle to fall asleep. This protein increases tryptophan levels, potentially leading to better sleep. In this trial, participants may receive a-lactalbumin protein as one of the treatment options. Another treatment arm involves casein protein, which studies indicate helps build muscle overnight, aiding in muscle recovery and potentially supporting better sleep by enhancing overall recovery. Participants may also receive carbohydrates, as some research suggests they can improve sleep quality by reducing nighttime awakenings, though effects may vary depending on the type and amount consumed. Each nutrient offers potential benefits in different ways, and results may differ based on individual needs. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for NCAA Division I female athletes who have been wearing a WHOOP 4.0 device for over 3 months. It's not suitable for those with musculoskeletal injuries, cardiometabolic diseases affecting practice, pre-diagnosed sleep conditions, or allergies to dietary supplements like lactose.

Inclusion Criteria

Wearing WHOOP 4.0 device for >3 months

I am a female athlete in NCAA Division I.

Exclusion Criteria

I have a sleep condition like sleep apnea that affects my sleep quality.

Allergy to any dietary supplement used in protocol - e.g., lactose intolerant

I have heart or metabolic conditions that prevent me from regular team activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants ingest 40 grams of a nutrient as a liquid shake for 3 consecutive nights in a randomized cross-over design

3 nights per intervention with at least 1 week washout period between each

In-person visits for each intervention start

Follow-up

Participants are monitored for sleep and recovery using WHOOP 4.0 device and subjective questionnaires

12 hours after ingestion for primary outcomes, continuous monitoring for secondary outcomes

What Are the Treatments Tested in This Trial?

Interventions

• a-lactalbumin Protein
• Carbohydrate
• Casein Protein
• Placebo

Trial Overview The study tests the impact of consuming different nutrients before bed on sleep and recovery in elite female athletes. Participants will randomly receive one of four shakes (Casein Protein, a-lactalbumin Protein, Carbohydrate, Placebo) each night for three nights with a week break between tests.

How Is the Trial Designed?

Group I: Casein Protein Active Control 1 Intervention

Each participant will consume a serving of casein protein mix.

Group II: a-lactalbumin Active Control 1 Intervention

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

Group III: Carbohydrate Active Control 1 Intervention

Each participant will consume a serving of carbohydrate mix.

Group IV: Placebo Placebo Group 1 Intervention

Each participant will consume a serving of a placebo mix.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Milk Specialties Global

Collaborator

Trials

1

Recruited

20+

Milk Specialties Global

Industry Sponsor

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9532617/

Carbohydrate and sleep: An evaluation of putative mechanisms Those consuming a low carbohydrate drink before bed were less aroused during the night, and reported better sleep quality (73).

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1491999/full

The relationship between carbohydrate intake and sleep ... In summary, a positive correlation was found between increased consumption of low-quality carbohydrates and an elevated risk of poor sleep ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33919698/

A Systematic Review, Meta-Analysis and Meta-Regression ... This study aimed to assess the effects of quantity, quality and periodization of carbohydrates consumption on sleep.

4. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-025-06068-4

The association between quality and quantity of carbohydrate ... Our study demonstrates a strong link between carbohydrate quantity and quality (based on fiber content and glycemic load) with sleep and mental health outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322007803

Effects of Diet on Sleep Quality Some found reduced SOL with the consumption of a higher carbohydrate diet (22, 23) but others reported a trend for greater SE after an acute intake of a very ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523279290

High-glycemic-index carbohydrate meals shorten sleep onset We showed that a carbohydrate-based high-GI meal resulted in a significant shortening of SOL in healthy sleepers compared with a low-GI meal.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8069918/

A Systematic Review, Meta-Analysis and Meta-Regression ... This study aimed to assess the effects of quantity, quality and periodization of carbohydrates consumption on sleep.

8. sleep.biomedcentral.com sleep.biomedcentral.com/articles/10.1186/s41606-023-00090-4

The effect of nutrition and physical activity on sleep quality ... Some researchers have shown that diets with high carbohydrates positively affect delaying sleep, and researchers have found that a diet rich in ...