Daily Egg Consumption and Cognitive Function in Older Adults

Cognition Clinical Trial

Official title: Daily Egg Consumption and Cognitive Function in Older Adults

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to test the effects of provisioning twelve eggs weekly, incorporated into breakfast meals, on composite scores of executive functioning and memory using the CNSVS computerized test platform in older adults in a randomized study.

Clinical Trial Description

Procedure: This study will test the effects of incorporating eggs at breakfast versus breakfasts that match a typical American breakfast on executive function and composite memory in adults 65 to 90 years old.

Randomization: Participants will be randomized using a permuted block randomization scheme to balance randomization across time with rolling enrollment, while ensuring allocation concealment through block sizes unknown to the investigators. Randomization will be also stratified by whether the individual participant is being randomized or multiple people from the same household (e.g., a couple being randomized together). This is to balance the number of randomized individual participants and households across the two conditions. Participants will be assigned sequentially

Analysis plan: An intention-to-treat analysis approach will be followed for data analysis. Primary statistical approach will be linear mixed models, including time, group, and their interaction as factors, where the interaction is the main test of interest to determine if the treatment group improved significantly more than the control group. The model will also include random effects for subjects (to account for repeated measurements) and for households (to adjust for clustering effect). Covariates for pre-randomization variables such as age, sex, education level, and computer familiarity may be included to account for variation in the outcomes and thereby improve power for the test of the intervention. For joint primary outcomes, we will split alpha of 0.05 between the two outcomes (p<0.025 for two-sided statistical significance). We will perform a compliers (threshold to be specified) and completers (those with both pre- and post-values) analysis as pre-specific secondary analyses on the primary outcomes. For pre-specified secondary outcomes, we will use the primary approach for the list of secondary outcomes. Results will be presented with and without multiple comparison or false discovery rate (FDR) corrections, and all analyzed outcomes will be reported. ;

Related Conditions & MeSH terms

• Cognition

• NCT number: NCT05460624
• Study type: Interventional
• Source: Indiana University
• Status: Withdrawn
• Phase: N/A
• Start date: February 10, 2023
• Completion date: February 10, 2023