Weight LossNCT00812162
Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
A study testing Energy Restriction in people with Weight Loss, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement). Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Energy Restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2011
- 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 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 21 years and older
- Body mass index between 25.0-39.9 kg/m2
- Weight stable (< 4.5 kg (~10 lbs) weight gain or loss within last 6 months)
- Body fat >25% (assessed by skinfold and plethysmography (if needed))
- Non-smoking (within the last 6 months)
- Constant habitual activity patterns (within last 3 months)
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- Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose <110 mg/dl)
- Not taking medications known to influence appetite or metabolism
- Non-diabetic
Who cannot join
- Age: <21 years
- Body mass index: outside of the 25.0-39.9 kg/m2 range
- Gained or lost > 4.5 kg (10 lbs) within the last 6 months
- Body fat <25% as assessed by plethysmography
- Smoker (currently or within the last 6 months)
- Intermittently been involved in a diet and/or exercise program within the last 3 months
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- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
- Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
- Clinically diagnosed as diabetic
- Allergies to eggs
- Lactose intolerance
- Clinically diagnosed with diverticulosis
- Clinically diagnosed with diverticulitis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).
- Conditions
- Weight Loss
- Being tested
- Energy Restriction
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy RestrictionOther
Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
Energy RestrictionOther
Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High protein diet. Receives: Other: Energy Restriction |
| 2 | Experimental | Lower protein diet. Receives: Other: Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to examine the effects of increased protein intake on appetite, selected appetite hormones (insulin, leptin, ghrelin), whole body energy expenditure, and body composition (fat mass and fat-free mass) changes.
Measured: 12 week
Secondary outcomes (1)
The secondary aim of this study is to evaluate the effects of meal frequency on appetite by asking the men to frequently rate their appetite on days that they purposefully eat 3 vs. 6 times/day.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph.D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812162
- Sponsor's protocol ID
- 0610004602
- Other IDs
- Pork Board 1320067860, Egg Board 1320067903
- Status last verified
- Jan 2013
- First submitted
- 18 Dec 2008
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
- ClinicalTrials.gov ID
- NCT00812162
- Acronym / sponsor ID
- 0610004602
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Dec 2008 (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 study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Energy RestrictionHigh protein diet. |
| 2 | Experimental | Other: Energy RestrictionLower protein diet. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age range: 21 years and older
- Body mass index between 25.0-39.9 kg/m2
- Weight stable (< 4.5 kg (~10 lbs) weight gain or loss within last 6 months)
- Body fat >25% (assessed by skinfold and plethysmography (if needed))
- Non-smoking (within the last 6 months)
Key exclusion criteria (13 listed)
- Age: <21 years
- Body mass index: outside of the 25.0-39.9 kg/m2 range
- Gained or lost > 4.5 kg (10 lbs) within the last 6 months
- Body fat <25% as assessed by plethysmography
- Smoker (currently or within the last 6 months)
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 |
|---|---|---|
| Energy RestrictionEnergy restricted diet of 750 kcal less than subjects requirement with a high protein diet. | Other | 1 |
| Energy RestrictionEnergy restricted diet of 750 kcal less than subjects requirement with a lower protein diet. | Other | 2 |
Primary outcome
The primary aim is to examine the effects of increased protein intake on appetite, selected appetite hormones (insulin, leptin, ghrelin), whole body energy expenditure, and body composition (fat mass and fat-free mass) changes.
Time frame: 12 week
1 secondary outcome
The secondary aim of this study is to evaluate the effects of meal frequency on appetite by asking the men to frequently rate their appetite on days that they purposefully eat 3 vs. 6 times/day.
Time frame: 12 week
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 17 Jan 2013.
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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.
Wayne W Campbell, Ph.D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Restriction in people with Weight Loss, run by Purdue University 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 9 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 17 Jan 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?
The primary aim is to examine the effects of increased protein intake on appetite, selected appetite hormones (insulin, leptin, ghrelin), whole body energy expenditure, and body composition (fat mass and fat-free mass) changes. (time frame: 12 week). 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 17 Jan 2013.