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

Primary Purpose

Appetite and General Nutritional Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise or Sedentary
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetite and General Nutritional Disorders focused on measuring Obesity, Appetite, Hormones, Exercise, Body Weight

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Energy Balance

Positive Energy Balance

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perceived subjective appetite measured by visual analog scales
Appetite questionnaires will be filled out hourly as well as every 30 minutes after meals from 8:00am to 11:00pm on the third and sixth day of each inpatient visit.
Energy intake at a breakfast buffet
A breakfast buffet will be served the morning after day 3 and day 6 of each inpatient visit to assess food intake following either energy balance (days 1-3) or overfeeding (days 4-6) with or without daily exercise.

Full Information

First Posted
May 5, 2011
Last Updated
July 22, 2013
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01354600
Brief Title
Effects of Positive Energy Balance and Exercise on Appetite Hormones in Sedentary Men and Women
Official Title
Short-term Positive Energy Balance and Exercise on 24-hour Plasma Levels of Hunger and Satiety Hormones in Sedentary Lean and Obese Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In a randomized cross-over design, participants will complete two separate six-day & seven night inpatient stays (separated by at least 4 weeks) at the University of Wisconsin Hospital's Clinical and Translational Research Core (CTRC). During each six-day & seven night visit, participants will be fed an energy balance diet (energy intake = energy expenditure) for the first three days followed by three days of overfeeding (130% of the energy balance diet). During one of the inpatient periods, participants will exercise twice daily (once in the morning, once in the evening) for a total of approximately 120 minutes per day on an indoor exercise bicycle at ~50% of maximal aerobic fitness. During the other inpatient visit, participants will not exercise and will be inactive. The investigators will examine the effect of short-term positive energy balance and exercise on 24-hour plasma levels of hormones related to hunger and satiety. These hormones include leptin, ghrelin, insulin, and peptide YY in sedentary lean and obese men and women. Our primary hypothesis is that when an obese person exercises, average 24-hour plasma leptin levels will increase in obese individuals during overfeeding compared to energy balance feeding, but fail to do so under sedentary conditions. In contrast, the investigators predict lean individuals will have an appropriate increase in average 24-hour leptin levels in response to overfeeding regardless of exercise treatment. Thus, the investigators suggest that a failure in the average 24-hour leptin response to overfeeding sets an obese person up for continued slow weight gain, as the leptin hunger signal fails to detect short-term overfeeding and does not produce a response. The investigators hypothesize that exercise will promote improved insulin sensitivity and increased leptin in the obese. The investigators predict that changes in average 24-hour plasma leptin levels will correlate with self-selected energy intake in lean individuals, but only during overfeeding plus exercise in obese individuals. In addition, because the hunger and satiety response in humans is complex, this study will characterize the average 24-hour plasma levels of ghrelin, which stimulates hunger, and peptide YY, which stimulate satiety or fullness, in lean and obese individuals to determine if plasma levels are altered in obesity and in response to short-term positive energy balance. Lastly, this study involves the banking of blood tissue specimens for future research. If it is decided such analysis is of scientific value, genetic analysis will be conducted for alterations in genes involved in the synthesis of, or receptors for, hunger and satiety hormones to be investigated under this study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite and General Nutritional Disorders
Keywords
Obesity, Appetite, Hormones, Exercise, Body Weight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy Balance
Arm Type
Other
Arm Title
Positive Energy Balance
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Exercise or Sedentary
Intervention Description
Daily cycling exercise at 50% maximal aerobic fitness for a total of ~120 minutes/day or no daily exercise (sedentary)
Primary Outcome Measure Information:
Title
Blood plasma appetite hormone concentrations
Description
Blood samples will be drawn over 24 hours on the third and sixth day of each inpatient visit.
Time Frame
Two separate six day & seven night inpatient visits, separated by at least 4 weeks.
Secondary Outcome Measure Information:
Title
Perceived subjective appetite measured by visual analog scales
Description
Appetite questionnaires will be filled out hourly as well as every 30 minutes after meals from 8:00am to 11:00pm on the third and sixth day of each inpatient visit.
Time Frame
Two separate six day & seven night inpatient visits, separated by at least 4 weeks.
Title
Energy intake at a breakfast buffet
Description
A breakfast buffet will be served the morning after day 3 and day 6 of each inpatient visit to assess food intake following either energy balance (days 1-3) or overfeeding (days 4-6) with or without daily exercise.
Time Frame
Two separate six day inpatient visits, separated by at least 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale A Schoeller, PhD
Organizational Affiliation
University of Wisconsin-Madison, Dept. of Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospitals, Clinical and Translational Research Core (CTRC)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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