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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598412
Other study ID # HGO-ICAAFyD18-6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 19, 2018
Est. completion date January 10, 2020

Study information

Verified date October 2020
Source Centro Universitario de Ciencias de la Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 protein content.


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.


Recruitment information / eligibility

Status Completed
Enrollment 522
Est. completion date January 10, 2020
Est. primary completion date December 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Community dwelling Exclusion Criteria: - Incomplete data registries

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 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 One day
Primary 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 One day
Primary 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). One day
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