NCT05217589

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

December 21, 2021

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Total GI symptom burden over a 30-minute jogging/running protocol.

  • 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.

    Change in emotion ratings between immediately pre-video and immediately post-video.

Secondary Outcomes (5)

  • Change over time in exercise heart rate

    Heart rate will be measured throughout a 30-minute treadmill jogging/running test. Change over time will be evaluated using mixed ANOVA.

  • Substrate use

    Carbohydrate and fat oxidation rates will be measured during the last 5 min of a 30-minute treadmill jogging/running test.

  • Feeling Scale

    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

    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

    Heart rate will be recorded immediately after videos are viewed.

Study Arms (3)

Funny/Amusing Video Clips

EXPERIMENTAL

Participants will watch 5-7-min video clips that are meant to be funny/amusing

Other: Funny/Amusing Video Clips

Horror/Scary Video Clips

EXPERIMENTAL

Participants will watch 5-7-min video clips that are meant to be scary

Other: Horror/Scary Video Clips

Thrilling/Suspenseful Video Clips

EXPERIMENTAL

Participants will watch 5-7-min video clips that are meant to be thrilling/suspenseful

Other: Thrilling/Suspenseful Video Clips

Interventions

Participants watch 5-7 minutes of video clips that are funny/amusing in nature

Funny/Amusing Video Clips

Participants watch 5-7 minutes of video clips that are scary in nature

Horror/Scary Video Clips

Participants watch 5-7 minutes of video clips that are thrilling/suspenseful in nature

Thrilling/Suspenseful Video Clips

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Patrick Wilson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Exercise Science

Study Record Dates

First Submitted

December 21, 2021

First Posted

February 1, 2022

Study Start

April 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations