AppetiteNCT01005563
Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss
A study testing Beef/Pork and Soy/Legumes in people with Appetite and Mood, run by Purdue University at 2 sites in United States.
Trial summary
The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appetite, Mood, Weight Loss
- What is being tested?
- Beef/Pork and Soy/Legumes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Sep 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 21 years and older
- Body mass index between 27.0-36.9 kg/m2
- Non-smoking (within the last 6 months)
- Weight stable (< 3 kg (~7 lbs) weight gain or loss within last 3 months)
- Energy need for weight maintenance 1950-2750 kcal/day
- Not dietary restrained
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- Menstruating women not pregnant or lactating
- Constant habitual activity patterns (within last 3 months)
- No Acute Illness (or have chronic diseases known to influence protein or energy metabolism)
- Non-diabetic
- Clinically normal blood profiles (within 10% of clinical normalcy)
- Non-hypertensive
- Not taking medications known to influence appetite or metabolism
- Willingness to eat study foods
- Able to travel to testing facility
Who cannot join
- Age: <21 years
- Body mass index: outside of the 27.0-36.9 kg/m2 range
- Smoker (currently or within the last 6 months)
- Gained or lost > 3.0 kg (7 lbs) within the last 3 months
- Energy need for weight maintenance < 1950 or > 2750 kcal/day
- Dietary restrained (≥ 14 on Three Factor Eating Questionnaire)
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- Pregnant, lactating, or non-menstruating women
- Clinically diagnosed as a diabetic, or with liver or kidney disease/dysfunction, or osteoporosis
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
- Hypertensive
- Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
- Allergies to eggs
- Lactose intolerance
- Unwillingness to eat study foods
- Inability to travel to testing facility
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Purdue University
West Lafayette, Indiana, 47906
Purdue University
West Lafayette, Indiana, 47907
About this study
The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.
- Conditions
- Appetite, Mood, Weight Loss
- Being tested
- Beef/Pork, Soy/Legumes
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beef/PorkOther
Participants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein
Soy/LegumesOther
Participants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Beef/Pork | Experimental | Participants consuming diet with beef/pork as predominate sources of protein Receives: Other: Beef/Pork |
| Arm 2: Soy/Legumes | Experimental | Participants consuming diet with soy/legumes as predominate sources of protein Receives: Other: Soy/Legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing protein intake from lean beef/pork or soy/legumes sources will result in progressively decreased daily composite hunger and desire to eat, and increased fullness. The responses will not be different between groups of subjects.
Measured: 14 weeks
Secondary outcomes (1)
Increasing the protein content of a test will result in progressively more robust and sustained changes in postprandial appetite and energy expenditure and blunted glycemic response. The responses will not be different between the groups of participants.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies 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
- 37 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
- NCT01005563
- Sponsor's protocol ID
- 0905008129
- Other IDs
- 0905008129
- Status last verified
- Mar 2014
- First submitted
- 30 Oct 2009
- Last updated
- 20 Mar 2014
- Results posted
- No
Publications
Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.
PubMed 26864362
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss
- ClinicalTrials.gov ID
- NCT01005563
- Acronym / sponsor ID
- 0905008129
- Conditions
- Appetite, Mood, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Nov 2009 (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 primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Beef/Pork | Experimental | Other: Beef/PorkParticipants consuming diet with beef/pork as predominate sources of protein |
| Arm 2: Soy/Legumes | Experimental | Other: Soy/LegumesParticipants consuming diet with soy/legumes as predominate sources of protein |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age range: 21 years and older
- Body mass index between 27.0-36.9 kg/m2
- Non-smoking (within the last 6 months)
- Weight stable (< 3 kg (~7 lbs) weight gain or loss within last 3 months)
- Energy need for weight maintenance 1950-2750 kcal/day
Key exclusion criteria (15 listed)
- Age: <21 years
- Body mass index: outside of the 27.0-36.9 kg/m2 range
- Smoker (currently or within the last 6 months)
- Gained or lost > 3.0 kg (7 lbs) within the last 3 months
- Energy need for weight maintenance < 1950 or > 2750 kcal/day
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 |
|---|---|---|
| Beef/PorkParticipants consuming diet containing 10, 20 or 30% dietary protein with beef/pork as the predominate sources of protein | Other | Arm 1: Beef/Pork |
| Soy/LegumesParticipants consuming diet containing 10, 20, or 30% dietary protein with soy/legumes as the predominate sources of protein. | Other | Arm 2: Soy/Legumes |
Primary outcome
Increasing protein intake from lean beef/pork or soy/legumes sources will result in progressively decreased daily composite hunger and desire to eat, and increased fullness. The responses will not be different between groups of subjects.
Time frame: 14 weeks
1 secondary outcome
Increasing the protein content of a test will result in progressively more robust and sustained changes in postprandial appetite and energy expenditure and blunted glycemic response. The responses will not be different between the groups of participants.
Time frame: 14 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 20 Mar 2014.
- Derived from this study: PubMed 26864362Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beef/Pork and Soy/Legumes in people with Appetite and Mood, run by Purdue University at 2 sites 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 15 inclusion and 15 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Increasing protein intake from lean beef/pork or soy/legumes sources will result in progressively decreased daily composite hunger and desire to eat, and increased fullness. The responses will not be different between groups of subjects. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005563, which also lists 1 linked publication.
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 20 Mar 2014.