Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters

April 11, 2024 updated by: Angelia Holland, Augusta University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Augusta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Works for local fire department, employed full-time

Exclusion Criteria:

  • Under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Did not receive peanut butter, maintained normal diet and activity. Asked to stop eating 2 hours prior to bed for 7 weeks.
Experimental: Peanut Butter
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.
Dietary supplement: Peanut Butter
2 tablespoons of peanut butter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Baseline
BIA to assess body fat and lean body mass.
Baseline
Body composition
Time Frame: Immediately after the intervention
BIA to assess body fat and lean body mass.
Immediately after the intervention
Sleep
Time Frame: 8 weeks
Assessed sleep throughout the study for 8 weeks via actigraph monitor
8 weeks
Blood pressure
Time Frame: Baseline
Assessed blood pressure
Baseline
Blood pressure
Time Frame: Immediately after the intervention
Assessed blood pressure
Immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 8 weeks
Assessed activity throughout the study for 8 weeks via actigraph monitor
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1928368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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