NCT05154422

Brief Summary

The popularity of marathons and endurance events has increased over the last few decades and, interestingly, the demographics of participants have also changed. From 1980 to 2002 the average race time to complete the marathon lengthened from \~3.5 hours to \~4.5 hours. Likewise, many endurance races include "Clydesdale" and "Athena" divisions for heavier weight male and female runners, respectively. As such, there has been an increase of overweight and obese participants in these races. For example, one study consisting of 250 runners determined, according to BMI, that approximately 15% and 31% of the female and male participants, respectively, were classified as overweight, with 31% and 33% classified as obese. Therefore, many recreational endurance athletes are overweight despite their high level of activity. On one hand, these data are positive as regular exercise reduces cardiovascular disease and all-cause mortality in overweight and obese populations. Yet, it is well documented in sedentary obese individuals that excess adiposity can lead to disturbances in adipocyte lipolysis and altered substrate utilization at rest and during exercise, and can decrease muscle quality. However, it is unknown if overweight individuals that exercise regularly have disrupted fat metabolism, circulating hormones, or muscle quality. No study has directly determined if differences exist in fat metabolism, circulating hormones, and muscle quality between overweight recreational female athletes and their lean counterparts when training status is equivalent. Therefore, the purpose of this investigation is to determine if differences in pre and post-exercise fat metabolism, circulating insulin and growth hormone, and muscle quality exist between active overweight individuals compared to active lean individuals with similar training history and who have regularly trained for and participated in endurance events within the last few years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

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

October 23, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
Last Updated

December 13, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

January 26, 2021

Last Update Submit

November 29, 2021

Conditions

Keywords

ObesityMuscle qualityInsulin SensitivityLipolysisMicrodialysisEndurance TrainingResistance TrainingExercise

Outcome Measures

Primary Outcomes (5)

  • Lipolysis

    Tested via microdialysis. Two probe inserted into the subcutaneous abdominal adipose tissue to collect glycerol molecules (byproduct of lipolysis).

    Second experimental visit for a total of 6 hours

  • Change in circulating insulin around an exercise bout

    Insulin will be collected via blood draws. Blood will be drawn immediately following metabolic testing for resting measurements, immediately after the bout of physical activity, and every hour for 120 minutes' post activity.

    Second experimental visit - Pre-exercise, Immediately post-exercise, and 120-minutes post-exercise

  • Change in circulating growth hormone around an exercise bout

    Growth hormone Insulin will be collected via blood draws. Blood will be drawn immediately following

    Second experimental visit - Pre-exercise, Immediately post-exercise, and 120-minutes post-exercise

  • Compositional Muscle Quality

    Intramuscular fat accumulation percentage will be measured and estimated using B-mode ultrasound echo intensity via histogram analysis and composition equations

    First experimental visit - 15 minutes

  • Functional Muscle Quality

    Functional MQ is measured via force production (via Biodex) divided muscle size (via dual energy X-ray absorptiometry).

    First experimental visit - 30 minutes

Secondary Outcomes (1)

  • Blood Sampling Analysis

    Second experimental visit - Pre-exercise, immediately after the resting metabolic measurements

Study Arms (2)

Normal body fat cohort

Determining the general amount of lipolysis, circulating insulin and growth hormone, and muscle quality of a group of recreational female endurance athletes with normal body fat determined by air displacement plethysmograph.

Excess body fat cohort

Determining the general amount of lipolysis, circulating insulin and growth hormone, and muscle quality of a group of recreational female endurance athletes with excess body fat determined by air displacement plethysmograph.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Fourteen active female endurance athletes (8 lower body fat, 6 higher body fat) will be recruited to participate in this study

You may qualify if:

  • Female participants will be recruited for the study
  • (BMI of \<29.9 kg/m2).
  • Ages of 18 and 45 years old
  • Weight stable (± 2 kg) for the last three months
  • Regularly endurance training on most days of the week for at least one hour for the last two years
  • Participants will be eumenorrheic and premenopausal

You may not qualify if:

  • Resting blood pressure above 160 mmHg systolic or 100 mmHg diastolic
  • Type 1 or type 2 diabetes; 3)
  • Other medical problems in which exercise is contraindicated
  • chronic infections
  • Diagnoses, signs, or symptoms of cardiovascular disease
  • Respiratory disease
  • Musculoskeletal disease
  • Musculoskeletal injuries in the last six months that would prevent them from engaging in endurance training.
  • Pregnant or lactating and must have a
  • Irregular menstrual cycle
  • Smoking
  • Diagnosed eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Science and Medicine, Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 26, 2021

First Posted

December 13, 2021

Study Start

October 23, 2020

Primary Completion

April 16, 2021

Study Completion

June 7, 2021

Last Updated

December 13, 2021

Record last verified: 2021-11

Locations