NCT05807334

Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern in Hyperlipidemic Adults

Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Cardio-Metabolic Risk Factors and Diet Quality in Hyperlipidemic Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Griffin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers and diet quality in hyperlipidemic adults.

Detailed description

This randomized, cross-over design, controlled trial will assess the effects of 8 weeks of daily inclusion of 2 whole eggs in the Dietary Approaches to Stop Hypertension (DASH) eating plan, compared with their exclusion, on cardio-metabolic risk markers, and diet quality in hyperlipidemic adults. Participants will be randomized to receive 1 of 2 treatment sequence permutations (i.e., DASH eating plan with eggs and DASH eating plan without eggs), with an 8-week washout period between treatment assignments. After randomization, participants will undergo a 4-week run-in period of a DASH eating plan without egg products before initiating the first of 2 treatment phases in their randomly-assigned sequence permutation. Specific Aims 1. To assess the effects of the inclusion of 2 whole eggs/day for 8 weeks in a DASH eating plan, as compared with their exclusion, on endothelial function measured as flow-mediated dilatation and on LDL cholesterol in hyperlipidemic adults. 2. To determine the effects of the inclusion of 2 whole eggs/day in the context of a DASH eating plan, as compared with their exclusion, on cardio-metabolic risk factors and diet quality in adults with hyperlipidemia over a period of 8 weeks.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
OTHER	DASH eating plan with eggs	Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to eat 2 whole eggs per day to supplement the DASH eating pattern.
OTHER	DASH eating plan without eggs	Participants will receive guidance to follow a DASH dietary pattern tailored to their caloric requirements and their personal and cultural food preferences, along with sample meal plans and other supplemental educational materials to help them adopt and maintain the dietary pattern during this study. During this 8-week phase, they will also be instructed to exclude eggs from their diet on a daily basis.

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-04-01
• Completion: 2024-07-01
• First posted: 2023-04-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States