Obesity3v6NCT01749449
Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss
A study testing protein and meal frequency in people with Obesity, run by Skidmore College at 1 site in United States.
Trial summary
The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- protein and meal frequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2007
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30-65 years old,
- overweight or obese but otherwise in good health
Who cannot join
- cardiovascular disease,
- cancer,
- HTN,
- type I or II DM,
- food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Protein Intake and Meal Frequency Reduces Abdominal Fat and Increases Postprandial Thermogenesis During Energy Balance and Energy Deficit
The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.
- Conditions
- Obesity
- Being tested
- protein and meal frequency
- Keywords
- high protein, high carbohydrate, meal frequency, abdominal body fat, postprandial thermogenesis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein and meal frequencyOther
comparison of different levels of protein intake and meal frequency on body composition in obese adults
| Study group | Role | What they receive |
|---|---|---|
| High protein 3 meals/day | Experimental | 35% protein intake eaten as 3 meals per day Receives: Other: protein and meal frequency |
| High carbohydrate consumed 3 meals/day | Experimental | High carbohydrate 3 meals/day Receives: Other: protein and meal frequency |
| High protein consumed 6 meals/day | Experimental | 35% protein 6 meals/day Receives: Other: protein and meal frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
DXA was used to quantify changes in body composition over the 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJan 2005
- Primary completionMay 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Paul J Arciero, PhD, Principal investigator, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749449
- Sponsor's protocol ID
- 3v6-021904
- Acronym
- 3v6
- Status last verified
- Jan 2007
- First submitted
- 11 Dec 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Protein Intake and Meal Frequency Reduces Abdominal Fat and Increases Postprandial Thermogenesis During Energy Balance and Energy Deficit
- ClinicalTrials.gov ID
- NCT01749449
- Acronym / sponsor ID
- 3v6 / 3v6-021904
- Conditions
- Obesity
- Keywords
- high protein, high carbohydrate, meal frequency, abdominal body fat, postprandial thermogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 13 Dec 2012 (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 the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High protein 3 meals/day | Experimental | Other: protein and meal frequency35% protein intake eaten as 3 meals per day |
| High carbohydrate consumed 3 meals/day | Experimental | Other: protein and meal frequencyHigh carbohydrate 3 meals/day |
| High protein consumed 6 meals/day | Experimental | Other: protein and meal frequency35% protein 6 meals/day |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 30-65 years old,
- overweight or obese but otherwise in good health
Key exclusion criteria (5 listed)
- cardiovascular disease,
- cancer,
- HTN,
- type I or II DM,
- food allergies
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 |
|---|---|---|
| protein and meal frequencycomparison of different levels of protein intake and meal frequency on body composition in obese adults | Other | High carbohydrate consumed 3 meals/day, High protein 3 meals/day, High protein consumed 6 meals/day |
Primary outcome
body composition
Time frame: 2 months
DXA was used to quantify changes in body composition over the 2 months
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 13 Dec 2012.
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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.
Paul J Arciero, PhD principal investigator
Skidmore College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein and meal frequency in people with Obesity, run by Skidmore College 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 2 inclusion and 5 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 13 Dec 2012. 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?
body composition (time frame: 2 months). 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 13 Dec 2012.