NCT04437550

Brief Summary

Interval exercise involves short bouts of high intensity exercise interspersed with periods of lower intensity exercise. The benefit is that a shorter total duration of exercise may be required to achieve cardiovascular benefits similar to or even superior to traditional longer bouts of steady state endurance exercise. However how this type of exercise affects appetite and energy intake, particularly in overweight and obese females is not well known. This study involves two trials of exercise, one at high intensity and one at low intensity, followed by a buffet lunch, in overweight and obese females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 15, 2020

Last Update Submit

June 16, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in energy expenditure

    caloric expenditure measured via indirect calorimetry

    immediately pre-breakfast, immediately pre-exercise, during exercise, and immediately post-exercise.

  • Change in energy intake

    measured via standardized lunch

    immediately post exercise

  • Change in appetite

    measured via circulating hormones leptin and acylated ghrelin

    immediately pre-breakfast, immediately post-breakfast, immediately post-exercise and immediately pre-lunch

  • Change in subjective hunger

    via visual analogue scale 100 mm, higher scores indicate greater hunger

    baseline, immediately pre-exercise, immediately post-exercise, immediately pre-lunch, and immediately post-lunch

Study Arms (2)

high-intensity

EXPERIMENTAL
Other: Exercise

low-intensity

EXPERIMENTAL
Other: Exercise

Interventions

high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max

high-intensitylow-intensity

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Adult
  • apparently healthy
  • overweight or class I obese
  • eumenorrheic

You may not qualify if:

  • Diabetes
  • pregnancy
  • cardiovascular disease
  • greater than 1 hour of structured physical activity per week
  • thyroid disease
  • polycystic ovary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Physiology Lab

Scranton, Pennsylvania, 18509, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations