Role of Acute Exercise Modality on Appetite Regulation and Energy Intake



Status:Recruiting
Conditions:Food Studies
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - 55
Updated:1/26/2019
Start Date:June 14, 2017
End Date:June 2019
Contact:Tanya M Halliday, PhD, RD
Email:tanya.halliday@ucdenver.edu
Phone:303-724-9083

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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.


Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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).

- 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.
We found this trial at
1
site
Aurora, Colorado 80045
Phone: 303-724-9083
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mi
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Aurora, CO
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