SleepNCT06364202
Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters
A study testing Peanut Butter in people with Sleep and Body Composition, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Body Composition, Blood Pressure
- What is being tested?
- Peanut Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Works for local fire department, employed full-time
Who cannot join
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels.
Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels
Read the detailed description
This study will utilize a randomized, parallel-arm, placebo-controlled design to determine the impact peanut butter consumption may have on sleep and energy levels in firefighters when consumed before bed-time. Forty local fire fighters will be recruited to complete this eight-week study; week one will constitute a baseline and weeks 2-8 will consist of the intervention. A blinded statistician will randomize the participants into one of two groups: a control group and a peanut butter group. During the first familiarization visit, all participants will sign an informed consent, receive height and weight measurements, waist and hip circumference measurements, blood pressure measurement, fill out a 30-day diet recall, fill out 3 questionnaires (Insomnia Severity Index, PTSD-checklist 5 (PCL-5), and Dispositional Resilience; will take 10 minutes to fill out) and receive a validated sleep monitor (Actigraph GT3X watch and heart rate monitor chest strap) and 14 Visual Analogue Scale (VAS) questionnaires which assess energy levels and time of last caffeine, alcohol, and screen time before bed. They will wear the watch for seven days along with the heart rate monitor for 5 nights and complete the VAS twice a day for seven days on qualtrics while maintaining a normal diet and physical activity. A link to take the surveys will be provided during the familiarization visit. After this baseline week, participants will then continue to wear the Actigraph watch daily for seven weeks and fill out a VAS twice a day while taking part in their specified intervention. Those in the control group will proceed with the same protocol as for the baseline week. Those in the peanut butter group will also continue with the same protocol as in the baseline week with the addition of consuming two tablespoons of peanut butter two hours before bed for five nights a week during the seven-week intervention. We will provide a tablespoon measurer and three jars of natural peanut butter to the participants in the peanut butter group. To increase ease of participation, we will meet in a private room at the local fire stations to collect data. Both the peanut butter and control group will be asked not to eat anything two hours before bed during those five days (after the peanut butter serving in the peanut butter group). The peanut butter consumption is dependent on randomization group assignment. Participants in both groups will be asked to maintain their normal diet and not change their physical activity levels and/or begin a weight loss program throughout their time in the study (approximately eight-weeks).
- Conditions
- Sleep, Body Composition, Blood Pressure, Physical Activity
- Being tested
- Peanut Butter
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut ButterDietary supplement
2 tablespoons of peanut butter
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Did not receive peanut butter, maintained normal diet and activity. Asked to stop eating 2 hours prior to bed for 7 weeks. |
| Peanut Butter | Experimental | Received and asked to consume 2 tbsp of peanut butter 2 hours before bedtime 5 nights per week for 7 weeks and to stop eating after that before bed. Other than that, asked to maintain normal diet and activity. Receives: Dietary Supplement: Peanut Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
BIA to assess body fat and lean body mass.
Measured: Baseline
Body composition
BIA to assess body fat and lean body mass.
Measured: Immediately after the intervention
Sleep
Assessed sleep throughout the study for 8 weeks via actigraph monitor
Measured: 8 weeks
Blood pressure
Assessed blood pressure
Measured: Baseline
Blood pressure
Assessed blood pressure
Measured: Immediately after the intervention
Secondary outcomes (1)
Physical activity
Assessed activity throughout the study for 8 weeks via actigraph monitor
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Aug 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelia Holland, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364202
- Sponsor's protocol ID
- 1928368
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kohler AA, Shuler DH, Adeleye LO, Moore AR, Peritore N, Winkler AM. A Pilot Randomized, Controlled Trial of Nighttime Peanut Butter Supplementation in Firefighters: Blood Pressure and Body Composition Outcomes. Diseases. 2026 Apr 8;14(4):135. doi: 10.3390/diseases14040135.
PubMed 42041627
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters
- ClinicalTrials.gov ID
- NCT06364202
- Acronym / sponsor ID
- 1928368
- Conditions
- Sleep, Body Composition, Blood Pressure, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 15 Apr 2024 (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 purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels.
Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels
Detailed description
This study will utilize a randomized, parallel-arm, placebo-controlled design to determine the impact peanut butter consumption may have on sleep and energy levels in firefighters when consumed before bed-time. Forty local fire fighters will be recruited to complete this eight-week study; week one will constitute a baseline and weeks 2-8 will consist of the intervention. A blinded statistician will randomize the participants into one of two groups: a control group and a peanut butter group. During the first familiarization visit, all participants will sign an informed consent, receive height and weight measurements, waist and hip circumference measurements, blood pressure measurement, fill out a 30-day diet recall, fill out 3 questionnaires (Insomnia Severity Index, PTSD-checklist 5 (PCL-5), and Dispositional Resilience; will take 10 minutes to fill out) and receive a validated sleep monitor (Actigraph GT3X watch and heart rate monitor chest strap) and 14 Visual Analogue Scale (VAS) questionnaires which assess energy levels and time of last caffeine, alcohol, and screen time before bed. They will wear the watch for seven days along with the heart rate monitor for 5 nights and complete the VAS twice a day for seven days on qualtrics while maintaining a normal diet and physical activity. A link to take the surveys will be provided during the familiarization visit. After this baseline week, participants will then continue to wear the Actigraph watch daily for seven weeks and fill out a VAS twice a day while taking part in their specified intervention. Those in the control group will proceed with the same protocol as for the baseline week. Those in the peanut butter group will also continue with the same protocol as in the baseline week with the addition of consuming two tablespoons of peanut butter two hours before bed for five nights a week during the seven-week intervention. We will provide a tablespoon measurer and three jars of natural peanut butter to the participants in the peanut butter group. To increase ease of participation, we will meet in a private room at the local fire stations to collect data. Both the peanut butter and control group will be asked not to eat anything two hours before bed during those five days (after the peanut butter serving in the peanut butter group). The peanut butter consumption is dependent on randomization group assignment. Participants in both groups will be asked to maintain their normal diet and not change their physical activity levels and/or begin a weight loss program throughout their time in the study (approximately eight-weeks).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Did not receive peanut butter, maintained normal diet and activity. Asked to stop eating 2 hours prior to bed for 7 weeks. |
| Peanut Butter | Experimental | Dietary Supplement: Peanut ButterReceived and asked to consume 2 tbsp of peanut butter 2 hours before bedtime 5 nights per week for 7 weeks and to stop eating after that before bed. Other than that, asked to maintain normal diet and activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Works for local fire department, employed full-time
Key exclusion criteria (1 listed)
- Under 18 years old
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 |
|---|---|---|
| Peanut Butter2 tablespoons of peanut butter | Dietary supplement | Peanut Butter |
Primary outcome
Body composition
Time frame: Baseline
BIA to assess body fat and lean body mass.
Body composition
Time frame: Immediately after the intervention
BIA to assess body fat and lean body mass.
Sleep
Time frame: 8 weeks
Assessed sleep throughout the study for 8 weeks via actigraph monitor
Blood pressure
Time frame: Baseline
Assessed blood pressure
Blood pressure
Time frame: Immediately after the intervention
Assessed blood pressure
1 secondary outcome
Physical activity
Time frame: 8 weeks
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 15 Apr 2024.
- Derived from this study: PubMed 42041627Kohler AA, Shuler DH, Adeleye LO, Moore AR, Peritore N, Winkler AM. A Pilot Randomized, Controlled Trial of Nighttime Peanut Butter Supplementation in Firefighters: Blood Pressure and Body Composition Outcomes. Diseases. 2026 Apr 8;14(4):135. doi: 10.3390/diseases14040135.
- Individual participant dataSharing planned: Undecided
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
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 Peanut Butter in people with Sleep and Body Composition, run by Augusta 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 1 inclusion and 1 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 15 Apr 2024. 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. 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?
Body composition (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06364202, which also lists 1 linked publication.
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 15 Apr 2024.