NCT04673721

PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (\~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.

Conditions

• Hypercholesterolemia
• Hyperlipidemia
• Vitamin Deficiency
• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fortified eggs	Average 12 eggs consumed per week
BEHAVIORAL	Intermittent fasting	16-hour fast and then an 8-hour nutritional window with aim for energy needs to be consumed during an 8 hour eating window (e.g., 11 am - 7 pm) with fasting for 16 hours (e.g., 7 pm - 11 am the next day).
DIETARY_SUPPLEMENT	Non-egg supplemented	2 or less eggs consumed per week
BEHAVIORAL	Usual care diet	Consistency with current diet without consideration of intermittent fasting

Timeline

• Start date: 2021-01-06
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2020-12-17
• Last updated: 2023-01-23

Locations

1 site across 1 country: United States