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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846440
Other study ID # HGO-ICAAFYD18-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date August 2017

Study information

Verified date March 2019
Source Centro Universitario de Ciencias de la Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Cross-sectional

Locations

Country Name City State
Mexico Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte Guadalajara Jalisco

Sponsors (2)

Lead Sponsor Collaborator
Centro Universitario de Ciencias de la Salud, Mexico Hospital General de Occidente

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functionality on Instrumental Activities of Daily Living 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
Primary Functionality on Activities of Daily Living 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
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