- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217589
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise
March 17, 2025 updated by: Patrick Wilson, PhD, Old Dominion University
Many athletes anecdotally report modifying their nutritional intake before competition in order to avoid gut problems, but no studies have evaluated whether emotional state impacts tolerance to pre-exercise feeding.
Therefore, this study will use movie clips (stressful, horror, and funny/amusing) to induce different mood states and emotions, which will be followed by ingestion of food before endurance running on a treadmill.
In addition, metabolic and physiologic responses to mood induction will be evaluated.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- 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 Contact
- Name: Patrick Wilson, PhD
- Phone Number: 7576834783
- Email: pbwilson@odu.edu
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Recruiting
- Human Performance Laboratory
-
Contact:
- Patrick Wilson
- Phone Number: 7576834783
- Email: pbwilson@odu.edu
-
-
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
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 18 to 55 years
- Able to run for 30 min at a moderate-to-vigorous intensity without stopping
- No diagnosis or signs/symptoms of cardiovascular disease (CVD) or metabolic disorders
- Currently physically active (at least 3 days/week of exercise at a moderate or higher intensity)
- No visual or hearing impairments interfering with ability to see and hear video clips
- No allergies to ingredients in Boost drink
Exclusion Criteria:
- Aged <18 or >55 years
- Unable to run for 30 min at a moderate-to-vigorous intensity without stopping
- A diagnosis or signs/symptoms of CVD or metabolic disorders
- Currently physically inactive (< 3 days/week of exercise at a moderate or higher intensity)
- Visual or hearing impairments interfering with ability to see and hear video clips
- Allergies to ingredients in Boost drink
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Funny/Amusing Video Clips
Participants will watch 5-7-min video clips that are meant to be funny/amusing
|
Participants watch 5-7 minutes of video clips that are funny/amusing in nature
|
|
Experimental: Horror/Scary Video Clips
Participants will watch 5-7-min video clips that are meant to be scary
|
Participants watch 5-7 minutes of video clips that are scary in nature
|
|
Experimental: Thrilling/Suspenseful Video Clips
Participants will watch 5-7-min video clips that are meant to be thrilling/suspenseful
|
Participants watch 5-7 minutes of video clips that are thrilling/suspenseful in nature
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total exercise gastrointestinal symptom burden
Time Frame: Total GI symptom burden over a 30-minute jogging/running protocol.
|
The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.
Ratings will be collected every 5 minutes during a 30-minute treadmill jogging/running test.
Scores from every 5-minute collection will be summed to calculate total GI symptom scores.
|
Total GI symptom burden over a 30-minute jogging/running protocol.
|
|
Change in emotion ratings
Time Frame: Change in emotion ratings between immediately pre-video and immediately post-video.
|
Anxiety, fear, happiness, amusement, disgust, sadness, and anger on a 0-9 Likert scale.
Emotions will be assessed before watching video clips and immediately after watching video clips.
|
Change in emotion ratings between immediately pre-video and immediately post-video.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change over time in exercise heart rate
Time Frame: Heart rate will be measured throughout a 30-minute treadmill jogging/running test. Change over time will be evaluated using mixed ANOVA.
|
Heart rate will be measured with a chest-strap (Polar) monitor.
|
Heart rate will be measured throughout a 30-minute treadmill jogging/running test. Change over time will be evaluated using mixed ANOVA.
|
|
Substrate use
Time Frame: Carbohydrate and fat oxidation rates will be measured during the last 5 min of a 30-minute treadmill jogging/running test.
|
Carbohydrate and fat oxidation rates will be estimated from the volumes of oxygen consumption and carbon dioxide production during exercise
|
Carbohydrate and fat oxidation rates will be measured during the last 5 min of a 30-minute treadmill jogging/running test.
|
|
Feeling Scale
Time Frame: Ratings on the Feeling Scale will be measured at rest before watching video clips and throughout (every 5 min) a subsequent 30-minute treadmill jogging/running test.
|
The Feeling Scale is a bipolar numerical rating scale ranging from -5 to +5, with descriptors of "very bad" at -5, "neutral" at 0, and "very good" at +5.
|
Ratings on the Feeling Scale will be measured at rest before watching video clips and throughout (every 5 min) a subsequent 30-minute treadmill jogging/running test.
|
|
Fatigue Scale
Time Frame: Ratings on the Fatigue Scale will be measured at rest before watching video clips and throughout (every 5 min) a subsequent 30-minute treadmill jogging/running test.
|
The Fatigue Scale is Likert-type scale that ranges from 0 (Not Fatigued at All) to 10 (Total Fatigue).
|
Ratings on the Fatigue Scale will be measured at rest before watching video clips and throughout (every 5 min) a subsequent 30-minute treadmill jogging/running test.
|
|
Heart rate post-video
Time Frame: Heart rate will be recorded immediately after videos are viewed.
|
Heart rate will be measured with a chest-strap (Polar) monitor.
|
Heart rate will be recorded immediately after videos are viewed.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2022
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
January 20, 2022
First Posted (Actual)
February 1, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 17, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infant, Newborn, Diseases
- Gastrointestinal Diseases
- Digestive System Diseases
- Colic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Neurotransmitter Agents
- Adrenocorticotropic Hormone
- Melanocyte-Stimulating Hormones
- beta-Endorphin
Other Study ID Numbers
- 21-180
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
product manufactured in and exported from the U.S.
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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