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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+