HealthyNCT01415973
Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
A study testing 3 ounces of cooked, 85% lean ground beef and 20 grams beef protein isolate in people with Healthy, run by University of Arkansas at 1 site in United States.
Trial summary
This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3 ounces of cooked, 85% lean ground beef and 20 grams beef protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2012
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female.
- Age 60 years or older.
Who cannot join
- Any (history of) gastrointestinal disease that interferes with GI function
- Diagnosed and active treatment of Diabetes Mellitus type I or II
- History of congestive heart failure
- Recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery)
- Myocardial infarction in the past year
- Infection or fever in the 7 days prior to enrollment
Show all 16Show fewer
- Current use of corticosteroids, growth hormone, or testosterone
- Adherence to a weight loss diet
- Use of protein-containing or amino acid-containing nutritional supplements within one week of enrollment
- Current alcohol (>7 ETOH per week) or drug abuse
- Platelet count (PLT) < 100,000
- History of hypo- or hyper-coagulation disorders including use of a coumadin derivative
- Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
- Allergy to local anesthetic
- Blood hemoglobin < 9.0 g/dL
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.
Read the detailed description
STUDY OBJECTIVES Primary: To compare the effects of consumption of a 3-ounce serving of beef to that of a 20g serving of BPI on skeletal muscle synthetic and breakdown rate in healthy elderly subjects.
Secondary: To investigate the effect the study products on plasma levels of amino acids, insulin, and glucose in healthy elderly subjects.
- Conditions
- Healthy
- Being tested
- 3 ounces of cooked, 85% lean ground beef, 20 grams beef protein isolate
- Keywords
- beef, protein, synergy, intact beef constituents, protein constituent, Nutrient Synergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 ounces of cooked, 85% lean ground beefDietary supplement
Consumed once per subject.
20 grams beef protein isolateDietary supplement
Subjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time.
| Study group | Role | What they receive |
|---|---|---|
| 3 ounces of cooked, 85% lean ground beef | Experimental | Subjects would consume 3 ounces of cooked, 85% lean ground beef at one setting on one day. Receives: Dietary Supplement: 3 ounces of cooked, 85% lean ground beef |
| 20 grams of Beef protein isolate | Experimental | Subjects would consume 20 grams of beef protein isolate dissolved into 200mL water at one setting on one day. Receives: Dietary Supplement: 20 grams beef protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle synthetic and breakdown rate
Using stable isotope infusion/ingestion methodology, we will measure plasma and skeletal muscle metabolic rate. Our primary end points will be muscle protein fractional synthesis rate (FSR) and whole body protein turnover rate.
Measured: day one
Secondary outcomes (1)
concentrations of plasma amino acids, insulin and glucose
Secondary endpoints are concentrations of plasma amino acids, insulin and glucose.
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert R Wolfe, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415973
- Sponsor's protocol ID
- UAMS IRB #132559
- Status last verified
- Jan 2012
- First submitted
- 10 Aug 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
- ClinicalTrials.gov ID
- NCT01415973
- Acronym / sponsor ID
- UAMS IRB #132559
- Conditions
- Healthy
- Keywords
- beef, protein, synergy, intact beef constituents, protein constituent, Nutrient Synergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Aug 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 will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.
Detailed description
STUDY OBJECTIVES Primary: To compare the effects of consumption of a 3-ounce serving of beef to that of a 20g serving of BPI on skeletal muscle synthetic and breakdown rate in healthy elderly subjects.
Secondary: To investigate the effect the study products on plasma levels of amino acids, insulin, and glucose in healthy elderly subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 ounces of cooked, 85% lean ground beef | Experimental | Dietary Supplement: 3 ounces of cooked, 85% lean ground beefSubjects would consume 3 ounces of cooked, 85% lean ground beef at one setting on one day. |
| 20 grams of Beef protein isolate | Experimental | Dietary Supplement: 20 grams beef protein isolateSubjects would consume 20 grams of beef protein isolate dissolved into 200mL water at one setting on one day. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female.
- Age 60 years or older.
Key exclusion criteria (16 listed)
- Any (history of) gastrointestinal disease that interferes with GI function
- Diagnosed and active treatment of Diabetes Mellitus type I or II
- History of congestive heart failure
- Recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery)
- Myocardial infarction in the past year
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 |
|---|---|---|
| 3 ounces of cooked, 85% lean ground beefConsumed once per subject. | Dietary supplement | 3 ounces of cooked, 85% lean ground beef |
| 20 grams beef protein isolateSubjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time. | Dietary supplement | 20 grams of Beef protein isolate |
Primary outcome
skeletal muscle synthetic and breakdown rate
Time frame: day one
Using stable isotope infusion/ingestion methodology, we will measure plasma and skeletal muscle metabolic rate. Our primary end points will be muscle protein fractional synthesis rate (FSR) and whole body protein turnover rate.
1 secondary outcome
concentrations of plasma amino acids, insulin and glucose
Time frame: day one
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 18 Jan 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Robert R Wolfe, PhD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 ounces of cooked, 85% lean ground beef and 20 grams beef protein isolate in people with Healthy, run by University of Arkansas 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 16 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 18 Jan 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?
skeletal muscle synthetic and breakdown rate (time frame: day one). 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 18 Jan 2012.