NCT05460624

Daily Egg Consumption and Cognitive Function in Older Adults

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cognition

Interventions

Type	Name	Description
OTHER	Egg-containing breakfast	Involves participants eating six premade egg-containing breakfast meals per week for 12 weeks. Each meal contains 2 eggs to provide 12 eggs per week.
OTHER	Typical American-style breakfast excluding eggs	Involves participants eating six premade egg-excluding breakfast meals per week for 12 weeks. Breakfast meals are matched to the intervention egg-containing breakfast meals on total energy and saturated fat and to the 'What We Eat in America' on percent energy from macronutrients.

Timeline

• Start date: 2023-02-10
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2022-07-15
• Last updated: 2023-02-28

Locations

1 site across 1 country: United States