Active Lifestyle MalesNCT00943436
The Effects of Exercise on Dietary Intake
A study testing Exercise Session and Rest Session in people with Active Lifestyle Males and Inactive Lifestyle Males, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Active Lifestyle Males, Inactive Lifestyle Males
- What is being tested?
- Exercise Session and Rest Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 20-25
- Percent body fat of 10-18%
- Exercises greater than or equal to 5 days/wk at 30 min/day or less than or equal to 1 day/week at 1 hour/day consistently for the past month
- Likes study foods
Who cannot join
- Does not fit in exercise criteria
- Allergies or unwillingness eat study food, falls
- From survey qualifies as a "conscious eater"
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, 37920
About this study
Official title: The Effects of Exercise on Energy Balance and Macronutrient Intake in College-aged Males
The purpose of this study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise.
Read the detailed description
Obesity is a consequence of positive energy balance, in which more energy is consumed than expended. It is hypothesized that regular amounts of physical activity may be important in helping individuals more accurately regulate energy balance. More research is needed to understand the impact of a physically active lifestyle on energy regulation capabilities Therefore, this study looks at sedentary college aged males compared to active college aged males when looking at two different sessions of energy expenditure, one exercise session and one resting session, and their energy and macronutrient intake after these sessions. The sessions will take place in the morning where each participant will exercise or rest and then be allowed to eat from a buffet ad libitum, where acute energy and macronutrient intake will be assessed.
The following hypotheses are proposed:
- Individuals who regularly engage in physical activity will more accurately respond to an energy deficit caused by an acute period of physical activity by increasing intake at a subsequent meal.
- Individuals who do not regularly engage in physical activity (sedentary individuals) will be less sensitive to accurately regulate energy balance and will not respond to an energy deficit caused by a period of acute physical activity.
- Conditions
- Active Lifestyle Males, Inactive Lifestyle Males
- Being tested
- Exercise Session, Rest Session
- Keywords
- Exercise, Sedentary, Energy Expenditure, Energy Balance, Macronutrient Intake, Energy and Macronutrient intake, Exercise and Energy Balance
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise SessionOther
This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Exercise Session" will consist of the participant coming into the lab and completing 45 min bout of exercise on an exercise bike, followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.
Rest SessionOther
This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Rest Session" will consist of the participant coming into the lab and completing a 45 min period of reading followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.
| Study group | Role | What they receive |
|---|---|---|
| Active males | Active comparator | Males who participate in at least 30 minutes of physical activity on 5 or more days per week for the last month. Receives: Other: Exercise Session; Other: Rest Session |
| Inactive males | Active comparator | Males who participate in less than 1 hour of physical activity per week for the last month. Receives: Other: Exercise Session; Other: Rest Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake at the Meal (Exercise Session)
Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Energy Intake at the Meal (Rest Session)
Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Carbohydrate at the Meal (Exercise Session)
Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Carbohydrate at the Meal (Rest Session)
carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Protein at the Meal (Exercise Session)
Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Protein at the Meal (Rest Session)
Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Fat at the Meal (Exercise Session)
Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Percent Energy From Fat at the Meal (Rest Session)
Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Lifestyle MalesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, PhD, RD, Study chair, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943436
- Sponsor's protocol ID
- Univ. of Tennessee IRB:7679B
- Status last verified
- Apr 2018
- First submitted
- 20 Jul 2009
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on Energy Balance and Macronutrient Intake in College-aged Males
- ClinicalTrials.gov ID
- NCT00943436
- Acronym / sponsor ID
- Univ. of Tennessee IRB:7679B
- Conditions
- Active Lifestyle Males, Inactive Lifestyle Males
- Keywords
- Exercise, Sedentary, Energy Expenditure, Energy Balance, Macronutrient Intake, Energy and Macronutrient intake, Exercise and Energy Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 13 Jul 2011
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 study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise.
Detailed description
Obesity is a consequence of positive energy balance, in which more energy is consumed than expended. It is hypothesized that regular amounts of physical activity may be important in helping individuals more accurately regulate energy balance. More research is needed to understand the impact of a physically active lifestyle on energy regulation capabilities Therefore, this study looks at sedentary college aged males compared to active college aged males when looking at two different sessions of energy expenditure, one exercise session and one resting session, and their energy and macronutrient intake after these sessions. The sessions will take place in the morning where each participant will exercise or rest and then be allowed to eat from a buffet ad libitum, where acute energy and macronutrient intake will be assessed.
The following hypotheses are proposed:
- Individuals who regularly engage in physical activity will more accurately respond to an energy deficit caused by an acute period of physical activity by increasing intake at a subsequent meal.
- Individuals who do not regularly engage in physical activity (sedentary individuals) will be less sensitive to accurately regulate energy balance and will not respond to an energy deficit caused by a period of acute physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active males | Active comparator | Other: Exercise Session, Other: Rest SessionMales who participate in at least 30 minutes of physical activity on 5 or more days per week for the last month. |
| Inactive males | Active comparator | Other: Exercise Session, Other: Rest SessionMales who participate in less than 1 hour of physical activity per week for the last month. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI of 20-25
- Percent body fat of 10-18%
- Exercises greater than or equal to 5 days/wk at 30 min/day or less than or equal to 1 day/week at 1 hour/day consistently for the past month
- Likes study foods
Key exclusion criteria (3 listed)
- Does not fit in exercise criteria
- Allergies or unwillingness eat study food, falls
- From survey qualifies as a "conscious eater"
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 SessionThis study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Exercise Session" will consist of the participant coming into the lab and completing 45 min bout of exercise on an exercise bike, followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum. | Other | Active males, Inactive males |
| Rest SessionThis study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Rest Session" will consist of the participant coming into the lab and completing a 45 min period of reading followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum. | Other | Active males, Inactive males |
Primary outcome
Energy Intake at the Meal (Exercise Session)
Time frame: 2 hours
Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Energy Intake at the Meal (Rest Session)
Time frame: 2 hours
Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Carbohydrate at the Meal (Exercise Session)
Time frame: 2 hours
Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Carbohydrate at the Meal (Rest Session)
Time frame: 2 hours
carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Protein at the Meal (Exercise Session)
Time frame: 2 hours
Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Protein at the Meal (Rest Session)
Time frame: 2 hours
Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Fat at the Meal (Exercise Session)
Time frame: 2 hours
Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Percent Energy From Fat at the Meal (Rest Session)
Time frame: 2 hours
Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hollie Raynor, PhD, RD study chair
University of Tennessee, Knoxville
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 Session and Rest Session in people with Active Lifestyle Males and Inactive Lifestyle Males, run by The University of Tennessee, Knoxville 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 4 inclusion and 3 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 29 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Energy Intake at the Meal (Exercise Session) (time frame: 2 hours). The study lists 8 primary outcomes in all. 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 29 Jun 2018.