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OpenTrials
Completed

NCT Number: NCT04245462

Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older

This study sought to determine if the number of meals per day with an adequate protein content (defined as eating >30 g protein or >0.4 g protein/kg body mass each) is associated with presenting physical disability in Mexican adults aged 60 years and older. Physical disability was evaluated with self-reported questionnaires for different activities of daily living.

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Key information

Conditions

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte

Guadalajara, Jalisco, 44430, Mexico

About this study

Detailed dietary information was obtained for each participant to estimate dietary protein intake per meal (breakfast, lunch, dinner). One meal was considered with adequate protein content if it contained >30 g or >0.4 g/kg. Then, the number of meals with an adequate protein content was counted and classified as Zero meals, One meal, or Two or Three meals.

Physical disability was assessed with two validated questionnaires. One for instrumental activities of daily living (Lawton) and another for activities of daily living (Barthel). Disability was classified for each questionnaire item according to the authors' scales. Most items considered a physical disability if the participant reported any difficulty performing that task.

To analyze the association between the number of meals with adequate protein content (predictive variable) and physical disability (outcome variable), we used binomial logistic regression for each item. For the number of meals, we set the group of Zero meals as the reference. The analyses were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate protein intake per day (<1.2 g/kg/d).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Cross-sectional

Primary outcomes

  1. Disability on Instrumental Activities of Daily Living

    Time frame: One day

    Disability reported for each item of instrumental activities of daily living (assessed with Lawton questionnaire). This instrument assesses how well the subject performs some daily activities involving tools (e.g. handling finances, taking medication, using the telephone). The instrument consists of five items for men and eight for women, and each item is coded for 0 (disabled) or 1 (functional) depending on if subjects are capable to successfully complete the activity. We only used the five items that apply for both men and women.

Secondary outcomes

  1. Disability on Activities of Daily Living

    Time frame: One day

    Disability reported for each item of activities of daily living (assessed with Barthel questionnaire). This instrument assesses how well the subject performs some daily activities (e.g. dressing, using stairs). The instrument consists of 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. When the subject performs the activity without difficulty (the highest score) he/she is deemed as functional, and any other difficulty as a disability.

Sponsors and collaborators

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Other

Collaborators

  • Hospital General de Occidente

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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