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Appetite RegulationNCT03143868

Role of Acute Exercise Modality on Appetite Regulation and Energy Intake

A study testing Exercise Modality in people with Appetite Regulation and Acute Exercise, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Appetite Regulation, Acute Exercise, Energy Intake
What is being tested?
Exercise Modality
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
14 Jun 2017to 3 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • History of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension (defined as: systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg, as measured during the screening visit with participants seated quietly, following established guidelines39), renal disease (e.g. chronic kidney disease, polycystic kidney disease, nephritis, etc.), hepatic disease (e.g. cirrhosis, liver failure, fatty liver, jaundice, etc.), untreated thyroid disease (e.g. Grave's disease, Hashimoto's disorder, goiters, thyroid cancers, etc.), or any other medical condition affecting weight or energy metabolism. Participants who are deemed ineligible based upon uncontrolled hypertension criteria will be referred to their primary care physicians for treatment. If this conditions become controlled they will be allowed to be re-evaluated for inclusion in the current trial.
  • 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).
Show all 18Show fewer
  • 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).
  • Unable or unwilling to undergo study procedures
  • Women who are peri- or post-menopausal, or report irregular menstrual cycles.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Denver - Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Being tested
Exercise Modality
Keywords
acute exercise, resistance exercise, aerobic exercise, appetite, energy intake

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise ModalityBehavioural

    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.

Study groups in NCT03143868
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalNot described
Receives: Behavioral: Exercise Modality
Resistance ExerciseExperimentalNot described
Receives: Behavioral: Exercise Modality
No ExercisePlacebo comparatorNot described
Receives: Behavioral: Exercise Modality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ghrelin Area Under the Curve (AUC)

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

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

  2. Change in Peptide YY (PYY) AUC

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

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

  3. 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)

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

Secondary outcomes (5)

  1. Change in Hunger AUC

    Subjective indicator of hunger values, overtime for each arm of the study. Evaluated via 100 mm visual analogue scales

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

  2. Change in Satiety AUC

    Subjective indicator of satiety values, overtime for each arm of the study. Evaluated via 100 mm visual analogue scales

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

  3. Change in Prospective Food Consumption AUC

    Subjective indicator of prospective food consumption values, overtime for each arm of the study. Evaluated via 100 mm visual analogue scales

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

  4. Change in Ad libitum Energy Intake - in lab

    In lab ad libitum buffet lunch (via weigh and measure methodology) at the end of each study arm visit

    Measured: 3 hours following breakfast meal on each arm

  5. Change in Ad libitum Energy Intake - free living

    3 days of free-living ad libitum energy intake (via self-report)

    Measured: For 3 days following each arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start14 Jun 2017
  3. Primary completion3 Jun 2019
  4. Study completion3 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143868
Sponsor's protocol ID
16-2697
Other IDs
UL1TR001082-04
Status last verified
Jun 2019
First submitted
2 May 2017
Last updated
4 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34516956

  • 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.

    PubMed 33831896

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Modality in people with Appetite Regulation and Acute Exercise, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ghrelin Area Under the Curve (AUC) (time frame: At baseline and every 30 minutes for 3 hours following a breakfast meal). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143868, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.

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