NCT03143868

Brief Summary

This study plans to learn more about how type of exercise influences measures of appetite regulation. In this study, investigators will be evaluating a resistance exercise session (using weight machines and free weights) and an aerobic exercise session (using a treadmill). Participants will also complete a sedentary control condition. A secondary purpose is to compare sex-based differences in appetite-indices in response to exercise. Therefore, the responses to aerobic and resistance exercise will also be compared between men and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration 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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

May 2, 2017

Last Update Submit

June 3, 2019

Conditions

Keywords

acute exerciseresistance exerciseaerobic exerciseappetiteenergy intake

Outcome Measures

Primary Outcomes (3)

  • Change in Ghrelin Area Under the Curve (AUC)

    Concentration of ghrelin values, overtime for each arm of the study

    At baseline and every 30 minutes for 3 hours following a breakfast meal

  • Change in Peptide YY (PYY) AUC

    Concentration of PYY values, overtime for each arm of the study

    At baseline and every 30 minutes for 3 hours following a breakfast meal

  • Change in GLP-1 AUC

    Concentration of GLP-1 values, overtime for each arm of the study. Added in December 2017 following receipt of additional funding to add this measure)

    At baseline and every 30 minutes for 3 hours following a breakfast meal

Secondary Outcomes (5)

  • Change in Hunger AUC

    At baseline and every 30 minutes for 3 hours following a breakfast meal

  • Change in Satiety AUC

    At baseline and every 30 minutes for 3 hours following a breakfast meal

  • Change in Prospective Food Consumption AUC

    At baseline and every 30 minutes for 3 hours following a breakfast meal

  • Change in Ad libitum Energy Intake - in lab

    3 hours following breakfast meal on each arm

  • Change in Ad libitum Energy Intake - free living

    For 3 days following each arm

Other Outcomes (2)

  • Difference Between Men and Women in Appetite-Indices

    At baseline, every 30 minutes for 3 hours following a breakfast meal, and for 3 days following each arm

  • Difference in Behavioral Economics Constructs (Delayed Discounting and Hypothetical Purchase Task)

    In the fed state, following completion of assigned exercise bout (or control bout).

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL
Behavioral: Exercise Modality

Resistance Exercise

EXPERIMENTAL
Behavioral: Exercise Modality

No Exercise

PLACEBO COMPARATOR
Behavioral: Exercise Modality

Interventions

The overall aim of this study is to compare how acute exercise modality (e.g. resistance exercise vs. aerobic exercise) differentially influence hormonal and behavioral indices of appetite regulation and ad libitum energy intake. Both conditions will also be compared to a non-exercise control condition.

Aerobic ExerciseNo ExerciseResistance Exercise

Eligibility Criteria

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

You may qualify if:

  • All ethnic groups and both genders
  • Age: 18-55 yrs (changed in September 2018 because trial we are modeling enrollment criteria on \[NCT02047721\] changed age range, so we adjusted for this trial as well)
  • BMI: 18.5-40 kg/m2 (changed in June 2018 from original range of 27-35 kg/m2 in order to improve recruitment. This is because recruitment within our prior BMI range had been slower than anticipated and potential participants that have expressed interest have screened out because of this. Given that we are still limiting enrollment criteria to adults who are inactive, it is likely that most will have body fat levels above normative standards, and therefore still be classified as having excess adiposity, even if their BMI is below 25 kg/m2. Furthermore, given the pilot nature of this work we believe it is important to complete the trial in a timely manner. We anticipate alterations to the enrollment criteria helping with this effort.)
  • Weight stable within ±5% in the last 6 months
  • Physically inactive (not meeting current physical activity guidelines, by self-report, no resistance training in previous 12-months)

You may not qualify if:

  • Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
  • Unable to exercise due to cardiac, pulmonary, neurologic or orthopedic reasons.
  • Significant gastrointestinal disorders including: inflammatory bowel disease requiring treatment within the past year, chronic malabsorptive conditions, chronic diarrhea, or active gallbladder disease.
  • Currently smoking and/or nicotine use within the past 6 months.
  • Treatment with medications known to significantly affecting appetite, weight, energy metabolism, energy intake or energy expenditure in the last 6 months (e.g. systemic corticosteroids, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
  • Weight loss or weight gain of \>5% in past 6 months.
  • History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons.
  • Currently pregnant (confirmed via urine pregnancy test), lactating or less than 6 months post-partum.
  • Self-report of alcohol or substance abuse within the past 12 months.
  • History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder, or score \>20 on the EATS-26. Participants with a score \>20 on the EATS-26 will be referred to their primary care physician for further evaluation.
  • Major psychiatric disorder (e.g. diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders).
  • Current severe depression or history of severe depression within the previous year (based on reported history, study physician examination findings, and/or a score \>21 on the CES-D). Participants meeting any of these criteria will be referred to their primary care physician and/or the emergency department (based upon study physician determined level of severity).
  • Significant food intolerances/allergies that cannot be accommodated by the CTRC Metabolic Kitchen.
  • Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
  • Other medical, psychiatric, or behavioral limitations that may interfere with participation (as determined by study physician).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

  • Tobin SY, Cornier MA, White MH, Hild AK, Simonsen SE, Melanson EL, Halliday TM. The effects of acute exercise on appetite and energy intake in men and women. Physiol Behav. 2021 Nov 1;241:113562. doi: 10.1016/j.physbeh.2021.113562. Epub 2021 Sep 10.

  • Halliday TM, White MH, Hild AK, Conroy MB, Melanson EL, Cornier MA. Appetite and Energy Intake Regulation in Response to Acute Exercise. Med Sci Sports Exerc. 2021 Oct 1;53(10):2173-2181. doi: 10.1249/MSS.0000000000002678.

Study Officials

  • Tanya M Halliday, PhD, RD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 8, 2017

Study Start

June 14, 2017

Primary Completion

June 3, 2019

Study Completion

June 3, 2019

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations