Low Protein Dietary IntakeNCT01171716
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
A study testing Meal Patterning in people with Low Protein Dietary Intake and High Protein Dietary Intake, run by Purdue University at 1 site in United States.
Trial summary
the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined. 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
- Low Protein Dietary Intake, High Protein Dietary Intake
- What is being tested?
- Meal Patterning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2008
- 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
- 21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body >25%, non smoking, clinically normal blood profiles, non-diabetic.
Who cannot join
- intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University, Dept of Foods and Nutrition
West Lafayette, Indiana, 47906
About this study
the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.
- Being tested
- Meal Patterning
- Keywords
- overweight, protein intake, satiety, eating, meal patterns
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal PatterningOther
LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals
| Study group | Role | What they receive |
|---|---|---|
| Dietary Protein Intake | Other | LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals Receives: Other: Meal Patterning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Protein Dietary IntakeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171716
- Sponsor's protocol ID
- 0708005744
- Status last verified
- Jan 2013
- First submitted
- 27 Jul 2010
- 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
- The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
- ClinicalTrials.gov ID
- NCT01171716
- Acronym / sponsor ID
- 0708005744
- Keywords
- overweight, protein intake, satiety, eating, meal patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Jul 2010 (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 the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Protein Intake | Other | Other: Meal PatterningLP intake 3 meals and 6 meals HP intake 3 meals and 6 meals |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 21 and older, BMI between 25.0-34.6, Weight Stable for at least 6 mths, body >25%, non smoking, clinically normal blood profiles, non-diabetic.
Key exclusion criteria (1 listed)
- intermittently been involved in a diet and/or exercise program within the last 3 months, Have no allergies to eggs.
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 |
|---|---|---|
| Meal PatterningLP intake 3 meals and 6 meals HP intake 3 meals and 6 meals | Other | Dietary Protein Intake |
Primary outcome
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
Time frame: 12 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 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Patterning in people with Low Protein Dietary Intake and High Protein Dietary Intake, 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 1 inclusion and 1 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 Body's Response to Changes in Dietary Protein and Meal-Frequency In Men (time frame: 12 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 17 Jan 2013.