MalnutritionNCT04655456
Feasibility of Estimating the Prevalence of Malnutrition, Frailty and Sarcopenia in Older People in UK Biobank, Cross-sectional Study: A Study Protocol
An observational study of Malnutrition and Frailty, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Frailty, Sarcopenia
- How many people
- 381,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2007to 20 Nov 2020
- How long will I take part?
- 14 Years
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Virtually all members of the general population are registered with a general practitioner through the NHS. Subsequently, recruitment was through NHS and all people aged 40-69 were eligible to participate. An invitation by mail was sent to those people who were living within reasonable travelling distance from assessment centres of UK Biobank. Additional information was collected prior sending an invitation; title, forename, gender, address, date of birth, name and address of General Practitioner and NHS number.
Who may be able to join
- The inclusion criteria will be both genders, age more than or equal to 50 years old, who completed the touchscreen questionnaire, 24-hour recall and physical measurements to enable the identification of malnutrition, frailty and sarcopenia.
Who cannot join
- Any participant who is under 50 or with incomplete information will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. The research is aiming to measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in older adults, using the UK Biobank. In addition, it will aim to compare the two models of frailty the phenotype and deficit accumulation using the UK Biobank database, as data comparing these models is limited.
Methods/design: This is a cross-sectional study design that will use the UK Biobank database, which includes 381,000 participants males and females, aged 50 years and above, who completed the UK Biobank baseline assessments were included that is a subset from the main sample size from the UK Biobank. For baseline, details of participant's characteristics will be included. All three conditions will be identified as malnutrition by using GLIM criteria, while frailty by using two models; the first model will be the 36 deficits model and phenotype model. Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models will be determining the feasibility to apply it using the available database in the UK Biobank.
Discussion: This proposed study will help in understanding the relation between malnutrition, frailty and sarcopenia. As in worldwide, there is little published research on the overlap between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria were developed for these conditions. There is conflict extend to the definitions and identification criteria's. This study will use UK Biobank database to measuring the estimate prevalence in older people and determine the overlap between three conditions.
Read the detailed description
The UK Biobank is a population-based study of a large prospective longitudinal cohort with information on 500,000 people, who were aged 40-69 when recruited in 2006-2010 from England, Scotland and Wales. The database includes demographic data, online questionnaires, X-rays and scan image of (brain, heart, abdomen, bones and carotid artery), as well as urine and saliva samples and blood biochemistry including: hormones and blood lipid. The online questionnaires (about: diet, cognitive function, work history and digestive health). It aims to improve the following: prevention, diagnosis and treatment for a broad number of diseases including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. This detailed information on participants provide a resource for investigators to conduct research related a particular diseases.
There are four phases of assessment in UK Biobank. The first phase was the UK Biobank Pilot assessment that included 3798 participants from Stockport only in 2006. Then, the second phase was the initial assessment visit that started in 2007 until 2010. This was the baseline assessment and included approximately 500000 participants. After that, the third phase was conducted and called the first repeat assessment visit which took place between 2012-2013 and included 20346 participants. Lastly, the imaging visit which is considered the fourth phase started in 2014 until present.
- Conditions
- Malnutrition, Frailty, Sarcopenia
- Keywords
- prevalence, older people
- Medical subject headings
- Malnutrition, Frailty, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of obtaining variables to be able to determine malnutrition, frailty and sarcopenia in the UK Biobank.
Determine if the variables in the UK biobank would be able to use different models to investigating malnutrition by mapping GLIM criteria, frailty by mapping it with two models 36 deficits and phenotype model. while sarcopenia will be matched with EWGSOP standard.
Measured: cross sectional, 2007
Measuring the prevalence of the three conditions by applying the models in UK Biobank.
Measuring the estimate prevalence of malnutrition, frailty and sarcopenia in older people using UK Biobank database.
Measured: cross sectional, 2007
Secondary outcomes (2)
Determine the overlap between three conditions in the baseline assessment
Frailty overlaps with sarcopenia and malnutrition due to similarities of outcome related to body weight. In addition, frailty and sarcopenia have recently had set definitions and diagnostic criteria
Measured: cross sectional, 2007
Compare prevalence results between different models
Estimating the frailty prevalence using two different measurement techniques the phenotype model with cumulative deficits model. In order to draw conclusion by comparing the results from each model.
Measured: cross sectional, 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Apr 2007
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
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 MalnutritionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 381,000 participants (actual)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Adnan AlMohaisen, University of Manchester
- Investigators
- Sorrel Burden, Study director, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655456
- Sponsor's protocol ID
- Manchester1
- Status last verified
- Apr 2021
- First submitted
- 30 Nov 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlMohaisen N, Gittins M, Todd C, Burden S. What is the overlap between malnutrition, frailty and sarcopenia in the older population? Study protocol for cross-sectional study using UK Biobank. PLoS One. 2022 Dec 6;17(12):e0278371. doi: 10.1371/journal.pone.0278371. eCollection 2022.
PubMed 36472992
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Estimating the Prevalence of Malnutrition, Frailty and Sarcopenia in Older People in UK Biobank, Cross-sectional Study: A Study Protocol
- ClinicalTrials.gov ID
- NCT04655456
- Acronym / sponsor ID
- Manchester1
- Conditions
- Malnutrition, Frailty, Sarcopenia
- Keywords
- prevalence, older people
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381,000 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 7 Dec 2020 (actual)
- 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.
Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. The research is aiming to measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in older adults, using the UK Biobank. In addition, it will aim to compare the two models of frailty the phenotype and deficit accumulation using the UK Biobank database, as data comparing these models is limited.
Methods/design: This is a cross-sectional study design that will use the UK Biobank database, which includes 381,000 participants males and females, aged 50 years and above, who completed the UK Biobank baseline assessments were included that is a subset from the main sample size from the UK Biobank. For baseline, details of participant's characteristics will be included. All three conditions will be identified as malnutrition by using GLIM criteria, while frailty by using two models; the first model will be the 36 deficits model and phenotype model. Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models will be determining the feasibility to apply it using the available database in the UK Biobank.
Discussion: This proposed study will help in understanding the relation between malnutrition, frailty and sarcopenia. As in worldwide, there is little published research on the overlap between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria were developed for these conditions. There is conflict extend to the definitions and identification criteria's. This study will use UK Biobank database to measuring the estimate prevalence in older people and determine the overlap between three conditions.
Detailed description
The UK Biobank is a population-based study of a large prospective longitudinal cohort with information on 500,000 people, who were aged 40-69 when recruited in 2006-2010 from England, Scotland and Wales. The database includes demographic data, online questionnaires, X-rays and scan image of (brain, heart, abdomen, bones and carotid artery), as well as urine and saliva samples and blood biochemistry including: hormones and blood lipid. The online questionnaires (about: diet, cognitive function, work history and digestive health). It aims to improve the following: prevention, diagnosis and treatment for a broad number of diseases including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. This detailed information on participants provide a resource for investigators to conduct research related a particular diseases.
There are four phases of assessment in UK Biobank. The first phase was the UK Biobank Pilot assessment that included 3798 participants from Stockport only in 2006. Then, the second phase was the initial assessment visit that started in 2007 until 2010. This was the baseline assessment and included approximately 500000 participants. After that, the third phase was conducted and called the first repeat assessment visit which took place between 2012-2013 and included 20346 participants. Lastly, the imaging visit which is considered the fourth phase started in 2014 until present.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Years
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Virtually all members of the general population are registered with a general practitioner through the NHS. Subsequently, recruitment was through NHS and all people aged 40-69 were eligible to participate. An invitation by mail was sent to those people who were living within reasonable travelling distance from assessment centres of UK Biobank. Additional information was collected prior sending an invitation; title, forename, gender, address, date of birth, name and address of General Practitioner and NHS number.
Key inclusion criteria (1 listed)
- The inclusion criteria will be both genders, age more than or equal to 50 years old, who completed the touchscreen questionnaire, 24-hour recall and physical measurements to enable the identification of malnutrition, frailty and sarcopenia.
Key exclusion criteria (1 listed)
- Any participant who is under 50 or with incomplete information will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the feasibility of obtaining variables to be able to determine malnutrition, frailty and sarcopenia in the UK Biobank.
Time frame: cross sectional, 2007
Determine if the variables in the UK biobank would be able to use different models to investigating malnutrition by mapping GLIM criteria, frailty by mapping it with two models 36 deficits and phenotype model. while sarcopenia will be matched with EWGSOP standard.
Measuring the prevalence of the three conditions by applying the models in UK Biobank.
Time frame: cross sectional, 2007
Measuring the estimate prevalence of malnutrition, frailty and sarcopenia in older people using UK Biobank database.
2 secondary outcomes
Determine the overlap between three conditions in the baseline assessment
Time frame: cross sectional, 2007
Compare prevalence results between different models
Time frame: cross sectional, 2007
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 30 Apr 2021.
- Derived from this study: PubMed 36472992AlMohaisen N, Gittins M, Todd C, Burden S. What is the overlap between malnutrition, frailty and sarcopenia in the older population? Study protocol for cross-sectional study using UK Biobank. PLoS One. 2022 Dec 6;17(12):e0278371. doi: 10.1371/journal.pone.0278371. eCollection 2022.
- Hereditary Hemochromatosis Associations with Frailty, SarcopThis is the title of a study used UK Biobank for two conditions frailty and sarcopenia. We are aiming to have similar method in measuring the conditionsLink provided by the sponsor.
- This study used UK Biobank in measuring the frailty condition for different age groups. We aimed using similar method in measuring frailtyLink provided by the sponsor.
- This study point out the overlap and evidence gaps in the diagnosis and treatment of frailty and malnutrition.Link provided by the sponsor.
- This is evidence that shows differences between two models in measuring frailty. As this study has one object in comparing the results from both models.Link provided by the sponsor.
- In this study we used the definition of sarcopenia and criteria of diagnosed in measuring the prevalence.Link provided by the sponsor.
- This study we used their definition of malnutrition and criteria of diagnosed.Link provided by the sponsor.
- 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.
Sorrel Burden study director
University of Manchester
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 Malnutrition and Frailty, run by University of Manchester at 1 site in United Kingdom.
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 1 inclusion and 1 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 30 Apr 2021. 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 Kingdom. 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?
Determine the feasibility of obtaining variables to be able to determine malnutrition, frailty and sarcopenia in the UK Biobank. (time frame: cross sectional, 2007). The study lists 2 primary outcomes in all. 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 NCT04655456, 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 30 Apr 2021.