Back to resultsThe Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise
Primary Purpose
Other Gastrointestinal Disorders, Cramp, Abdominal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Funny/Amusing Video Clips
Horror/Scary Video Clips
Thrilling/Suspenseful Video Clips
Sponsored by
About this trial
This is an interventional basic science trial for Other Gastrointestinal Disorders
Eligibility Criteria
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
Sites / Locations
- Human Performance LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Funny/Amusing Video Clips
Horror/Scary Video Clips
Thrilling/Suspenseful Video Clips
Arm Description
Participants will watch 5-7-min video clips that are meant to be funny/amusing
Participants will watch 5-7-min video clips that are meant to be scary
Participants will watch 5-7-min video clips that are meant to be thrilling/suspenseful
Outcomes
Primary Outcome Measures
Total exercise gastrointestinal symptom burden
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.
Change in emotion ratings
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.
Secondary Outcome Measures
Change over time in exercise heart rate
Heart rate will be measured with a chest-strap (Polar) monitor.
Substrate use
Carbohydrate and fat oxidation rates will be estimated from the volumes of oxygen consumption and carbon dioxide production during exercise
Feeling Scale
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.
Fatigue Scale
The Fatigue Scale is Likert-type scale that ranges from 0 (Not Fatigued at All) to 10 (Total Fatigue).
Heart rate post-video
Heart rate will be measured with a chest-strap (Polar) monitor.
Full Information
NCT ID
NCT05217589
First Posted
December 21, 2021
Last Updated
April 18, 2022
Sponsor
Old Dominion University
1. Study Identification
Unique Protocol Identification Number
NCT05217589
Brief Title
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise
Official Title
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Old Dominion University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Gastrointestinal Disorders, Cramp, Abdominal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Funny/Amusing Video Clips
Arm Type
Experimental
Arm Description
Participants will watch 5-7-min video clips that are meant to be funny/amusing
Arm Title
Horror/Scary Video Clips
Arm Type
Experimental
Arm Description
Participants will watch 5-7-min video clips that are meant to be scary
Arm Title
Thrilling/Suspenseful Video Clips
Arm Type
Experimental
Arm Description
Participants will watch 5-7-min video clips that are meant to be thrilling/suspenseful
Intervention Type
Other
Intervention Name(s)
Funny/Amusing Video Clips
Intervention Description
Participants watch 5-7 minutes of video clips that are funny/amusing in nature
Intervention Type
Other
Intervention Name(s)
Horror/Scary Video Clips
Intervention Description
Participants watch 5-7 minutes of video clips that are scary in nature
Intervention Type
Other
Intervention Name(s)
Thrilling/Suspenseful Video Clips
Intervention Description
Participants watch 5-7 minutes of video clips that are thrilling/suspenseful in nature
Primary Outcome Measure Information:
Title
Total exercise gastrointestinal symptom burden
Description
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.
Time Frame
Total GI symptom burden over a 30-minute jogging/running protocol.
Title
Change in emotion ratings
Description
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.
Time Frame
Change in emotion ratings between immediately pre-video and immediately post-video.
Secondary Outcome Measure Information:
Title
Change over time in exercise heart rate
Description
Heart rate will be measured with a chest-strap (Polar) monitor.
Time Frame
Heart rate will be measured throughout a 30-minute treadmill jogging/running test. Change over time will be evaluated using mixed ANOVA.
Title
Substrate use
Description
Carbohydrate and fat oxidation rates will be estimated from the volumes of oxygen consumption and carbon dioxide production during exercise
Time Frame
Carbohydrate and fat oxidation rates will be measured during the last 5 min of a 30-minute treadmill jogging/running test.
Title
Feeling Scale
Description
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.
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.
Title
Fatigue Scale
Description
The Fatigue Scale is Likert-type scale that ranges from 0 (Not Fatigued at All) to 10 (Total Fatigue).
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.
Title
Heart rate post-video
Description
Heart rate will be measured with a chest-strap (Polar) monitor.
Time Frame
Heart rate will be recorded immediately after videos are viewed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Wilson, PhD
Phone
7576834783
Email
pbwilson@odu.edu
Facility Information:
Facility Name
Human Performance Laboratory
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Wilson
Phone
757-683-4783
Email
pbwilson@odu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise
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