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

Obesity Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04673721
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date January 6, 2021
Completion date December 13, 2022
View Details
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