Effects of Positive Energy Balance and Exercise on Appetite Hormones in Sedentary Men and Women

NCT01354600 | Completed

• 1 other identifier: H-2009-0001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effects of overfeeding and exercise on blood levels of hormones associated with regulating appetite, also thought of as feelings of hunger and satiety (fullness). Previous studies have shown that non-obese people have different amounts of these hormones in their blood compared to obese people. The investigators hypothesize that exercise will promote improved insulin sensitivity and corresponding beneficial changes in obese individuals. The investigators predict exercise induced changes in 24-hour plasma hormone levels will be associated with improved appetite during overfeeding in obese individuals.

Conditions

Appetite and General Nutritional Disorders

Keywords

Obesity; Appetite; Hormones; Exercise; Body Weight

Outcome Measures

Primary Outcomes (1)

• Blood plasma appetite hormone concentrations

  Blood samples will be drawn over 24 hours on the third and sixth day of each inpatient visit.

  Two separate six day & seven night inpatient visits, separated by at least 4 weeks.

Secondary Outcomes (2)

• Perceived subjective appetite measured by visual analog scales

  Two separate six day & seven night inpatient visits, separated by at least 4 weeks.

• Energy intake at a breakfast buffet

  Two separate six day inpatient visits, separated by at least 4 weeks.

Study Arms (2)

Energy Balance

OTHER

Other: Exercise or Sedentary

Positive Energy Balance

OTHER

Other: Exercise or Sedentary

Interventions

Exercise or Sedentary OTHER

Daily cycling exercise at 50% maximal aerobic fitness for a total of \~120 minutes/day or no daily exercise (sedentary)

Energy Balance; Positive Energy Balance

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy body mass index (BMI) = 19 \< 25 kg/m2
• Obese BMI = 30 \< 35 kg/m2
• Activity level = sedentary: Total energy expenditure/resting metabolic rate \< 1.6 (average US adult level)

You may not qualify if:

• Tobacco use
• Regular exercise or physical activity, defined as \> 2h/week of moderate to vigorous activity;
• Individuals who do not eat breakfast
• Weight loss of \> 3% of body weight over the previous six months
• Eating a special diet (e.g., vegetarian or low-carbohydrate)
• Current diagnosis of, or using prescription medications for, thyroid dysfunction, type I or type II diabetes, hypertension, cardiovascular, kidney, or liver disease;
• Taking other prescription medications or over-the-country products that alter energy metabolism (other than birth control pills)
• Allergies to any of the foods used in the study
• Individuals who donated blood within 8 weeks prior to enrollment or who plan to give blood during the course of the study
• Claustrophobia
• History of exercise intolerance, including diagnosed exercise induced asthma or any physical limitations to seated cycling aerobic exercise
• Blood chemistries in excess of 130% of the upper normal level and/or hemoglobin or hematocrit below the normal range.
• Females that are pregnant (pregnancy status to be tested at the beginning of each 6-day metabolic chamber stay), lactating, or have irregular menses

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospitals, Clinical and Translational Research Core (CTRC)

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Body Weight

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dale A Schoeller, PhD

  University of Wisconsin-Madison, Dept. of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 17, 2011
• Study Start: May 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

US (1)