Appetite and General Nutritional DisordersNCT01354600
Effects of Positive Energy Balance and Exercise on Appetite Hormones in Sedentary Men and Women
A study testing Exercise or Sedentary in people with Appetite and General Nutritional Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite and General Nutritional Disorders
- What is being tested?
- Exercise or Sedentary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Feb 2012
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals, Clinical and Translational Research Core (CTRC)
Madison, Wisconsin, 53792
About this study
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
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.
Read the 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.
- Being tested
- Exercise or Sedentary
- Keywords
- Obesity, Appetite, Hormones, Exercise, Body Weight
- Medical subject headings
- Obesity, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise or SedentaryOther
Daily cycling exercise at 50% maximal aerobic fitness for a total of ~120 minutes/day or no daily exercise (sedentary)
| Study group | Role | What they receive |
|---|---|---|
| Energy Balance | Other | Not described Receives: Other: Exercise or Sedentary |
| Positive Energy Balance | Other | Not described Receives: Other: Exercise or Sedentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood plasma appetite hormone concentrations
Blood samples will be drawn over 24 hours on the third and sixth day of each inpatient visit.
Measured: 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
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.
Measured: Two separate six day & seven night inpatient visits, separated by at least 4 weeks.
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.
Measured: Two separate six day inpatient visits, separated by at least 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMay 2009
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetite and General Nutritional DisordersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale A Schoeller, PhD, Principal investigator, University of Wisconsin-Madison, Dept. of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354600
- Sponsor's protocol ID
- H-2009-0001
- Status last verified
- Jul 2013
- First submitted
- 5 May 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01354600
- Acronym / sponsor ID
- H-2009-0001
- Keywords
- Obesity, Appetite, Hormones, Exercise, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Balance | Other | Other: Exercise or Sedentary |
| Positive Energy Balance | Other | Other: Exercise or Sedentary |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise or SedentaryDaily cycling exercise at 50% maximal aerobic fitness for a total of ~120 minutes/day or no daily exercise (sedentary) | Other | Energy Balance, Positive Energy Balance |
Primary outcome
Blood plasma appetite hormone concentrations
Time frame: Two separate six day & seven night inpatient visits, separated by at least 4 weeks.
Blood samples will be drawn over 24 hours on the third and sixth day of each inpatient visit.
2 secondary outcomes
Perceived subjective appetite measured by visual analog scales
Time frame: Two separate six day & seven night inpatient visits, separated by at least 4 weeks.
Energy intake at a breakfast buffet
Time frame: Two separate six day inpatient visits, separated by at least 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale A Schoeller, PhD principal investigator
University of Wisconsin-Madison, Dept. of Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise or Sedentary in people with Appetite and General Nutritional Disorders, run by University of Wisconsin, Madison 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 3 inclusion and 13 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 23 Jul 2013. 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. 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?
Blood plasma appetite hormone concentrations (time frame: Two separate six day & seven night inpatient visits, separated by at least 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2013.