- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846440
Inadequate Protein Intake at Specific Meals and Functionality in Middle to Older Aged Mexican Adults
Study Overview
Detailed Description
Detailed dietary information was obtained for each participant to estimate dietary protein intake per meal (breakfast, lunch, dinner). One meal was considered with inadequate protein intake if its content was <30 g or 0.4 g/kg.
Functionality was assessed with two validated questionnaires. One for instrumental activities of daily living (Lawton) and another for activities of daily living (Barthel). We calculated a score according to each author's scales. This score was divided into three possible groups as "low", "middle", and "high" scores.
To analyze the association between inadequate protein intake per meal and functionality, we used multinomial logistic regression. The outcome variable was functionality ("High" was the reference group, "middle" and "low" scores were considered as impaired functionality), and the predictive variables were inadequate protein intake at breakfast, lunch, and dinner. They were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate protein intake per day (<1.2 g/kg/d).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44430
- Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects able to stand up and walk independently or with walking sticks only.
- Subjects able to answer questionnaires independently or with minimum caregivers' assistance.
Exclusion Criteria:
- Subjects reporting any kind of hospitalization within the last year.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants
Middle to older aged (>50 years) Mexican adults attending to the Geriatrics Department from the Western General Hospital (Zapopan, Jalisco,Mexico).
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Cross-sectional
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality on Instrumental Activities of Daily Living
Time Frame: One day
|
Functionality score for instrumental activities of daily living (assessed with Lawton questionnaire).
This instrument assess how well the subject perform some daily activities involving tools (e.g.
handling finances, taking medication, using the telephone).
The instrument consists on five items for men and eight for women, and each item is coded for 0 or 1 depending on if subjects are capable to successfully complete the activity.
Therefore, the score ranges from 0 to 5 in men and 0 to 8 in women, the higher the score, the more functional the subject.
|
One day
|
Functionality on Activities of Daily Living
Time Frame: One day
|
Functionality score for activities of daily living (assessed with Barthel questionnaire).
This instrument assess how well the subject perform some daily activities (e.g.
dressing, using stairs).
The instrument consists on ten items for both men and women coded as 0 or multiples of 5 (i.e. 5, 10, 15) depending on if subjects are capable to successfully complete the activity.
The score ranges from 0 to 100 for both men and women, the higher the score, the more functional the subject.
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One day
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HGO-ICAAFYD18-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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