Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-29 @ 7:10 PM
Study NCT ID:
NCT01354600
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2011-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Positive Energy Balance and Exercise on Appetite Hormones in Sedentary Men and Women
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: