Inadequate Protein Intake at Specific Meals and Functionality in Middle to Older Aged Mexican Adults

March 9, 2019 updated by: Juan Ricardo Lopez y Taylor, Centro Universitario de Ciencias de la Salud, Mexico
This study sought to determine if the inadequate protein intake per meal (defined as eating <30 g protein or 0.4 g protein/kg body mass) at specific meals (breakfast, lunch, dinner) is associated with functionality in middle to older aged Mexican adults. Functionality was evaluated with self-reported questionnaires to assess their functionality score for different activities of daily living.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44430
        • Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Middle to older aged Mexican adults attending to the Geriatrics Department at the Western General Hospital (Hospital General de Occidente) for their usual medical screening or first time assessment.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
Cross-sectional

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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 17, 2019

First Submitted That Met QC Criteria

February 17, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 9, 2019

Last Verified

March 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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