Muscle CompositionS25NCT01396915
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
An observational study of Muscle Composition and Sarcopenia, run by Purdue University at 1 site in United States.
Trial summary
This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Composition, Sarcopenia, Hypertrophy
- What is being tested?
- Dietary Protein Intake
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2014
- Phase
- Observational
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and Women between the ages of 65-80
Who may be able to join
- Men and Women between the ages of 55-80
- Body Mass Index between 27-35
- Non Diabetic
- Normal liver, kidney and heart functions within 10% of clinical normalcy
- Not currently following a weight loss or other special /non balanced diets
- weight stable
Who cannot join
- fasting glucose > 110 mg/dl
- blood pressure > 160/110 mm Hg
- plasma total cholesterol > 260 mg/dl
- LDL-cholesterol >160mg/dl
- triacylglycerol>400 mg/dl
- >than 1 hour/week of habitual aerobic and /or resistance exercise
- Currently taking prescribed blood thinners
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.
- Conditions
- Muscle Composition, Sarcopenia, Hypertrophy, Inflammation
- Being tested
- Dietary Protein Intake
- Keywords
- Skeletal muscle lipid content, whole muscle volume, fasting glucose, insulin, blood urea nitrogen
- Medical subject headings
- Sarcopenia, Hypertrophy, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Protein IntakeDietary supplement
Dietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1)
| Study group | Role | What they receive |
|---|---|---|
| High or Normal Dietary Protein Intake | Not described Receives: Dietary Supplement: Dietary Protein Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults
Anticipated subject recruitment completion
Measured: December 31, 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle CompositionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 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
- NCT01396915
- Sponsor's protocol ID
- 1101010282
- Acronym
- S25
- Status last verified
- May 2013
- First submitted
- 11 Feb 2011
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
- ClinicalTrials.gov ID
- NCT01396915
- Acronym / sponsor ID
- S25 / 1101010282
- Conditions
- Muscle Composition, Sarcopenia, Hypertrophy, Inflammation
- Keywords
- Skeletal muscle lipid content, whole muscle volume, fasting glucose, insulin, blood urea nitrogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jul 2011 (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.
This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High or Normal Dietary Protein Intake | – | Dietary Supplement: Dietary Protein Intake |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and Women between the ages of 65-80
Key inclusion criteria (6 listed)
- Men and Women between the ages of 55-80
- Body Mass Index between 27-35
- Non Diabetic
- Normal liver, kidney and heart functions within 10% of clinical normalcy
- Not currently following a weight loss or other special /non balanced diets
Key exclusion criteria (7 listed)
- fasting glucose > 110 mg/dl
- blood pressure > 160/110 mm Hg
- plasma total cholesterol > 260 mg/dl
- LDL-cholesterol >160mg/dl
- triacylglycerol>400 mg/dl
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 |
|---|---|---|
| Dietary Protein IntakeDietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1) | Dietary supplement | High or Normal Dietary Protein Intake |
Primary outcome
Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults
Time frame: December 31, 2013
Anticipated subject recruitment completion
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 4 Feb 2016.
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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?
An observational study of Muscle Composition and Sarcopenia, 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 6 inclusion and 7 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 4 Feb 2016. 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?
Effects of Increased, Egg-Based Protein Intake on Muscle Composition, Metabolic Health and Systemic Inflammation in Obese, Older Adults (time frame: December 31, 2013). 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 4 Feb 2016.