MedTrace Logo

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

NCT04673721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-01-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Robert Mentz, MD, FACC, FAHA, FHFSA · Duke Cardiovascular Disease Fellowship

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2022-12-13
Completion
2022-12-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673721 on ClinicalTrials.gov