Protein-energy; ImbalanceNCT01193946
Assessment of Dietary Protein Needs of Older Women
An observational study of Protein-energy; Imbalance, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate dietary protein requirements in elderly women aged 80 years and older using the indicator amino acid oxidation technique. Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated average requirement of 0.66 g∙kg-1∙d-1 protein. Read more about this study
- Who is it for?
- Ages 80 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Protein-energy; Imbalance
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2011
- 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 80 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Female Age range: 80 yrs and older Body mass index between 22-30 Weight stable 4.5 kg weight gain or loss within the last 6 month Non-smoking within the last 6 month Ambulatory Clinically normal blood profiles within 10% of clinical normalcy. No diseases or not taking medications known to influence protein or energy metabolism, Willingness and ability to consume food provided and not allergic to phenylalanine
Who may be able to join
- Female
- Age range: 80 yrs and older
- Body mass index between 22-30
- Weight stable 4.5 kg weight gain or loss within the last 6 month
- Non-smoking within the last 6 month
- Ambulatory
Show all 10Show fewer
- Clinically normal blood profiles within 10% of clinical normalc.
- No diseases or not taking medications known to influence protein or energy metabolism,
- Willingness and ability to consume food provided and not allergic to phenylalanine
- Continent, strong bladder control
Who cannot join
- Male,
- Gained or lost more than 4.5 kg of body weight within the last 6 months,
- Non-ambulatory (i.e. bedridden, wheel-chair bound),
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate dietary protein requirements in elderly women aged 80 years and older using the indicator amino acid oxidation technique.
Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.
Read the detailed description
There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research.
- Conditions
- Protein-energy; Imbalance
- Being tested
- dietary control
- Keywords
- Protein requirement, Elderly women, Indicator amino acid oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary controlDietary supplement
Seven dietary protein levels will be tested randomly on the 7 testing days: 0.10, 0.30, 0.60, 0.90, 1.2, 1.5, and 1.8 g∙kg-1∙d-1.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm design | There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research Receives: Dietary Supplement: dietary control |
What is being measured
The primary outcome is the main question the study is designed to answer.
dietary protein requirement in older women
Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionDec 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 Protein-energy; ImbalanceStudies 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
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- 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
- NCT01193946
- Sponsor's protocol ID
- 1001008857
- Other IDs
- UL1RR025761
- Status last verified
- Jan 2013
- First submitted
- 27 Jul 2010
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang M, McCabe GP, Elango R, Pencharz PB, Ball RO, Campbell WW. Assessment of protein requirement in octogenarian women with use of the indicator amino acid oxidation technique. Am J Clin Nutr. 2014 Apr;99(4):891-8. doi: 10.3945/ajcn.112.042325. Epub 2014 Jan 15.
PubMed 24429540
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
- Assessment of Dietary Protein Needs of Older Women
- ClinicalTrials.gov ID
- NCT01193946
- Acronym / sponsor ID
- 1001008857
- Conditions
- Protein-energy; Imbalance
- Keywords
- Protein requirement, Elderly women, Indicator amino acid oxidation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Sep 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 evaluate dietary protein requirements in elderly women aged 80 years and older using the indicator amino acid oxidation technique.
Hypothesis to be tested: Protein requirement for elderly women is higher than the estimated average requirement of 0.66 g∙kg-1∙d-1 protein. The recommended protein intake for elderly women is higher than the recommended dietary allowance of 0.80 g∙kg-1∙d-1 protein.
Detailed description
There is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm design | – | Dietary Supplement: dietary controlThere is currently considerable debate regarding the accuracy of the estimated average requirement (EAR) and the recommended dietary allowance (RDA) for older people. Very limited data obtained from older individuals are available to support the assumption that age does not affect protein requirement. Existing method like nitrogen balance has inherent limitations that diminish it from being considered a reference method. Indicator amino acid oxidation technique is emerging as an alternative method to measure dietary protein requirement. It is more accurate and less demanding. The current study will be the first time this technique is used with elderly adults and will provide an important foundation for geriatric nutrition research |
Who may qualify
- Ages
- 80 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Female Age range: 80 yrs and older Body mass index between 22-30 Weight stable 4.5 kg weight gain or loss within the last 6 month Non-smoking within the last 6 month Ambulatory Clinically normal blood profiles within 10% of clinical normalcy. No diseases or not taking medications known to influence protein or energy metabolism, Willingness and ability to consume food provided and not allergic to phenylalanine
Key inclusion criteria (10 listed)
- Female
- Age range: 80 yrs and older
- Body mass index between 22-30
- Weight stable 4.5 kg weight gain or loss within the last 6 month
- Non-smoking within the last 6 month
Key exclusion criteria (4 listed)
- Male,
- Gained or lost more than 4.5 kg of body weight within the last 6 months,
- Non-ambulatory (i.e. bedridden, wheel-chair bound),
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
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 controlSeven dietary protein levels will be tested randomly on the 7 testing days: 0.10, 0.30, 0.60, 0.90, 1.2, 1.5, and 1.8 g∙kg-1∙d-1. | Dietary supplement | Single-arm design |
Primary outcome
dietary protein requirement in older women
Time frame: 3 month
Dietary protein requirement is assessed by the subjects' differential response to different dietary protein intake
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.
- Derived from this study: PubMed 24429540Tang M, McCabe GP, Elango R, Pencharz PB, Ball RO, Campbell WW. Assessment of protein requirement in octogenarian women with use of the indicator amino acid oxidation technique. Am J Clin Nutr. 2014 Apr;99(4):891-8. doi: 10.3945/ajcn.112.042325. Epub 2014 Jan 15.
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 Protein-energy; Imbalance, 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 10 inclusion and 4 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?
dietary protein requirement in older women (time frame: 3 month). 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 NCT01193946, 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 17 Jan 2013.