AgingNCT04598412
Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries
An observational study of Aging, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
The researchers will compare protein intake patterns per day and per meal among older adults from different countries. The analysis will also compare the proportion of inadequate protein intake per day (different cut points), per meal (breakfast, lunch, dinner), and the number of meals per day that reach an adequate… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 522 participants
- Where
- 1 siteMexico
- Study dates
- 19 Aug 2018to 10 Jan 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community dwelling older adults (>60 y) from different countries.
Who may be able to join
- Community dwelling
Who cannot join
- Incomplete data registries
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
Guadalajara, Jalisco, 44430
About this study
The researchers will compare protein intake patterns per day and per meal among older adults from different countries. The analysis will also compare the proportion of inadequate protein intake per day (different cut points), per meal (breakfast, lunch, dinner), and the number of meals per day that reach an adequate protein content.
Read the detailed description
There will be a literature review in search of other studies reporting protein intake patterns in older adults. These studies must report total, and per-meal protein intake, evaluated through 24-h dietary recalls, food diaries or food frequency questionnaires. Afterwards, the researchers will contact the authors for data requests and analyze the data; these data will also include some demographic variables (e.g. sex, age, height, weight). Once the data are obtained, the patterns of protein intake will be compared among countries with an ANOVA test. As it is very likely that variances and/or sample sizes will be unequal, a Welch's correction and a Dunnett test for post hoc analyses will be performed. This analysis is going to be performed for the whole sample and by sex. Similarly, the proportion of older adults that do not reach the recommended amounts of protein in a daily (0.8, 1.0, 1.2 g/kg/day) and per meal basis (30 g, 0.4 g/kg) will be calculated. These proportions will be compared among countries with a chi-squared test and employing a z-test for proportions (with Bonferroni adjustment) to identify pairwise differences.
- Conditions
- Aging
- Being tested
- No intervention
- Keywords
- Protein intake, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Cross-sectional
| Study group | Role | What they receive |
|---|---|---|
| Mexican sample | Aged >60 years (n = 187) Receives: Other: No intervention | |
| German sample | Aged >75 years (n = 97) Receives: Other: No intervention | |
| Northamerican sample | Aged >60 years (n = 200) Receives: Other: No intervention | |
| British sample | Aged >70 years (n = 38) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate protein intake per day
Percentage of older adults that did not eat enough protein per day according to the following cut points: 0.8, 1.0, and 1.2 g/kg/d
Measured: One day
Inadequate protein intake per meal
Percentage of older adults that did not eat enough protein per meal according to the following cut points: 30 g/meal, or 0.4 g/kg/meal
Measured: One day
Meals per day with adequate protein content
The number of meals per day that had enough protein (>30 g/meal, or >0.4 g/kg/meal).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start19 Aug 2018
- Primary completion27 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General de Occidente
- Responsible party
- Principal investigator, Juan Ricardo Lopez y Taylor, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Alejandro Gaytán-González, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598412
- Sponsor's protocol ID
- HGO-ICAAFyD18-6
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries
- ClinicalTrials.gov ID
- NCT04598412
- Acronym / sponsor ID
- HGO-ICAAFyD18-6
- Conditions
- Aging
- Keywords
- Protein intake, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Collaborators
- Hospital General de Occidente
- Study start
- 19 Aug 2018 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 22 Oct 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.
The researchers will compare protein intake patterns per day and per meal among older adults from different countries. The analysis will also compare the proportion of inadequate protein intake per day (different cut points), per meal (breakfast, lunch, dinner), and the number of meals per day that reach an adequate protein content.
Detailed description
There will be a literature review in search of other studies reporting protein intake patterns in older adults. These studies must report total, and per-meal protein intake, evaluated through 24-h dietary recalls, food diaries or food frequency questionnaires. Afterwards, the researchers will contact the authors for data requests and analyze the data; these data will also include some demographic variables (e.g. sex, age, height, weight). Once the data are obtained, the patterns of protein intake will be compared among countries with an ANOVA test. As it is very likely that variances and/or sample sizes will be unequal, a Welch's correction and a Dunnett test for post hoc analyses will be performed. This analysis is going to be performed for the whole sample and by sex. Similarly, the proportion of older adults that do not reach the recommended amounts of protein in a daily (0.8, 1.0, 1.2 g/kg/day) and per meal basis (30 g, 0.4 g/kg) will be calculated. These proportions will be compared among countries with a chi-squared test and employing a z-test for proportions (with Bonferroni adjustment) to identify pairwise differences.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mexican sample | – | Other: No interventionAged >60 years (n = 187) |
| German sample | – | Other: No interventionAged >75 years (n = 97) |
| Northamerican sample | – | Other: No interventionAged >60 years (n = 200) |
| British sample | – | Other: No interventionAged >70 years (n = 38) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling older adults (>60 y) from different countries.
Key inclusion criteria (1 listed)
- Community dwelling
Key exclusion criteria (1 listed)
- Incomplete data registries
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 |
|---|---|---|
| No interventionCross-sectional | Other | British sample, German sample, Mexican sample, Northamerican sample |
Primary outcome
Inadequate protein intake per day
Time frame: One day
Percentage of older adults that did not eat enough protein per day according to the following cut points: 0.8, 1.0, and 1.2 g/kg/d
Inadequate protein intake per meal
Time frame: One day
Percentage of older adults that did not eat enough protein per meal according to the following cut points: 30 g/meal, or 0.4 g/kg/meal
Meals per day with adequate protein content
Time frame: One day
The number of meals per day that had enough protein (>30 g/meal, or >0.4 g/kg/meal).
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 26 Oct 2020.
- 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.
Alejandro Gaytán-González principal investigator
University of Guadalajara
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 Aging, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
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 26 Oct 2020. 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 Mexico. 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?
Inadequate protein intake per day (time frame: One day). The study lists 3 primary outcomes in all. 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 26 Oct 2020.