Older AdultsNCT02971059
Phenylalanine Requirement of Adults >65 Years.
A study testing Phenylalanine intake in people with Older Adults, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Currently there are insufficient published studies on amino acid requirements in the elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been observed in in the blood of older adults. It is due the increased uptake by the liver and intestine. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Phenylalanine intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Jun 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy elderly males and females > 65 years
- Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
- No recent history of weight loss
- Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- Non-smoking
- Willingness to consume the diet provided
Who cannot join
- Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
- On medications known to affect protein and amino acid metabolism (steroids).
- Recent significant weight loss.
- Individual on weight reducing diets.
- Inability to tolerate the diet
- Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
- Significant coffee consumption of more than 2 cups/day
- Significant alcohol consumption of more than one drink/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenylalanine Requirement of Healthy Older Adult Males and Females > 65 Years Determined by Direct Amino Acid Oxidation (DAAO) Method.
Currently there are insufficient published studies on amino acid requirements in the elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been observed in in the blood of older adults. It is due the increased uptake by the liver and intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle protein synthesis. Requirement for elderly individuals have been set based on studies conducted in younger adults hence may be inaccurate. The goal of this study is to directly measure the phenylalanine requirement of male and female elderly subjects over 65 years using the direct amino acid oxidation (DAAO) technique.
Read the detailed description
- To determine and compare the phenylalanine requirement of healthy elderly male and female adults over the age of 65 years using the DAAO technique (by measuring the oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] ) in response to graded intakes of phenylalanine.
- To compare the requirement so derived to that of young healthy adult previously determined in our lab.
- Conditions
- Older Adults
- Being tested
- Phenylalanine intake
- Keywords
- Elderly, Phenylalanine, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylalanine intakeDietary supplement
Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Adult Males >65 years | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours. Receives: Dietary Supplement: Phenylalanine intake |
| Adult Females >65 years | Experimental | Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours. Receives: Dietary Supplement: Phenylalanine intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine Requirement
To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2018
- Study completionJun 2018
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 Older AdultsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, Principal investigator, Hospital for Sick Children, Toronto, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971059
- Sponsor's protocol ID
- 1000051682
- Status last verified
- Sep 2018
- First submitted
- 14 Nov 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Martin KE, Pencharz PB, Rafii M, Ball RO, Szwiega S, Elango R, Courtney-Martin G. The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults. J Nutr. 2019 Oct 1;149(10):1776-1784. doi: 10.1093/jn/nxz137.
PubMed 31271193
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylalanine Requirement of Healthy Older Adult Males and Females > 65 Years Determined by Direct Amino Acid Oxidation (DAAO) Method.
- ClinicalTrials.gov ID
- NCT02971059
- Acronym / sponsor ID
- 1000051682
- Conditions
- Older Adults
- Keywords
- Elderly, Phenylalanine, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Nov 2016 (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.
Currently there are insufficient published studies on amino acid requirements in the elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been observed in in the blood of older adults. It is due the increased uptake by the liver and intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle protein synthesis. Requirement for elderly individuals have been set based on studies conducted in younger adults hence may be inaccurate. The goal of this study is to directly measure the phenylalanine requirement of male and female elderly subjects over 65 years using the direct amino acid oxidation (DAAO) technique.
Detailed description
- To determine and compare the phenylalanine requirement of healthy elderly male and female adults over the age of 65 years using the DAAO technique (by measuring the oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] ) in response to graded intakes of phenylalanine.
- To compare the requirement so derived to that of young healthy adult previously determined in our lab.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Males >65 years | Experimental | Dietary Supplement: Phenylalanine intakeParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours. |
| Adult Females >65 years | Experimental | Dietary Supplement: Phenylalanine intakeParticipants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Healthy elderly males and females > 65 years
- Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
- No recent history of weight loss
- Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- Non-smoking
Key exclusion criteria (8 listed)
- Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
- On medications known to affect protein and amino acid metabolism (steroids).
- Recent significant weight loss.
- Individual on weight reducing diets.
- Inability to tolerate the diet
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 |
|---|---|---|
| Phenylalanine intakePhenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day | Dietary supplement | Adult Females >65 years, Adult Males >65 years |
Primary outcome
Phenylalanine Requirement
Time frame: Baseline
To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes
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 Sep 2018.
- Derived from this study: PubMed 31271193Martin KE, Pencharz PB, Rafii M, Ball RO, Szwiega S, Elango R, Courtney-Martin G. The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults. J Nutr. 2019 Oct 1;149(10):1776-1784. doi: 10.1093/jn/nxz137.
- Individual participant dataSharing planned: No
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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.
Glenda Courtney-Martin principal investigator
Hospital for Sick Children, Toronto, Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylalanine intake in people with Older Adults, run by The Hospital for Sick Children at 1 site in Canada.
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 8 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 Sep 2018. 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 Canada. 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?
Phenylalanine Requirement (time frame: Baseline). 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 NCT02971059, 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 18 Sep 2018.