Egg Intake, Metabolic Outcomes and Choline Levels

May 9, 2026 updated by: Clara Cho, University of Guelph

Additional Daily Intake of Eggs for Improving Metabolic Outcomes and Choline Levels in Individuals With Obesity: Phase I Study

The purpose of this research is to determine the effect of additional daily egg intake on metabolic phenotypes and metabolism in the context of obesity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Choline-derived phosphatidylcholine has diverse functions including being necessary for packaging and exporting triglycerides from the liver. Choline deficiency induces fatty liver, which occurs very commonly in overweight and obesity, emphasizing the importance of choline in lipid metabolism. Studies suggest the role of gut microbiota and host genetics in influencing choline availability, which gut microbes can convert choline to trimethylamine, and hepatically oxidized by flavin monooxygenase 3 to trimethylamine-N-oxide (TMAO), a recently emerged marker of disease. We have recently shown that phosphatidylcholine (the major form of choline in food) leads to higher plasma concentrations of choline without raising TMAO compared to no choline control, which metabolic heterogeneity in TMAO response that appears to be a function of individual gut microbiota composition. However, the effect of phosphatidylcholine on parameters of liver health and function in the context of obesity has not been examined. This study will leverage a whole-food approach using eggs, which are enriched in phosphatidylcholine, as a modulator of metabolic health with a focus on interindividual variation in response.

The study objectives are: 1) determine the effect of additional daily intake of eggs on metabolic outcomes (liver density and enzymes, circulating lipids and glucose levels, body mass index and adiposity); 2) assess the effects of additional daily intake of eggs on levels of choline and downstream metabolites including TMAO; 3) determine the relation between outcome variables in response to additional daily intake of eggs and metabolic modifiers including the gut microbiota composition and genetic polymorphism. To achieve these objectives, Phase I of the larger study will be conducted, which will have multiple "hits" to form the basis of targetable outcomes. Participants will be asked to keep their habitual diet during the 4-week baseline period, followed by 4 weeks of additional daily intake of 3 whole eggs (intervention) then 4 weeks without daily intake of eggs as a washout. Participants will be free-living and will not be supplied with any other food except for the eggs during the intervention period with no restrictions of energy intake. Participants will make clinic visits every 4 weeks for 12 weeks. At their first visit (week 0), before the intervention (week 4), after the intervention (week 8) and after the washout (week 12), participants will arrive overnight-fasted and liver imaging will be performed. Fasting blood will be obtained by a phlebotomist using a standard venipuncture procedure. Anthropometric measures including waist and hip circumferences and BMI will be collected. Participants will also be asked to turn in their fecal sample in a thermos-insulated bag with ice packs. All samples will be de-identified, distributed among storage vials and stored at -80°C until further analyses.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Research Center of the Institut universitaire de cardiologie et de pneumologie de Québec - ULaval
        • Contact:
        • Sub-Investigator:
          • Mathieu C. Morissette, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female participant of any race or ethnicity between 30-65 (inclusive) years of age
  • BMI > 30 kg/m2
  • Non-smoker
  • Willing to consume 3 eggs per day for one dietary period of 4 weeks
  • Willing to avoid eggs during the rest of the study except for eggs that are provided
  • Willing to follow the study protocol including maintaining usual lifestyle during the entire study

Exclusion Criteria:

  • Age < 30 or > 65 years
  • BMI < 30 kg/m2
  • Vegans or individuals who do not consume eggs
  • Individuals who are currently pregnant or planning to become pregnant during the course of the study; or are currently breastfeeding
  • Smokers, users of recreational drugs
  • Individuals taking antibiotics or natural health products including prebiotics or probiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 weeks of additional daily intake of 3 whole eggs
No intervention: 4 weeks of habitual diet without daily intake of eggs (baseline) will be followed by 4 weeks of additional daily intake of 3 whole eggs then no intervention: 4 weeks of habitual diet without daily intake of eggs (washout)
Dietary supplement: 3 whole eggs
Participants will be free-living and will not be supplied with any other food except for the eggs during the intervention period with no restrictions of energy intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of circulating liver enzymes
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Body mass index in kg/m^2
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Body circumference in metrics
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Liver physical density by imaging technologies
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Liver morphology as assessed by imaging technologies
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Concentration of circulating lipid markers
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Concentration of circulating glucose markers
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Choline metabolite response
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Trimethylamine-N-oxide metabolite response
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12
Flavin monooxygenase 3 (FMO3) 472 G>A genetic polymorphism
Time Frame: Week 0
Week 0
Composition of fecal microbiota
Time Frame: Weeks 0, 4, 8 and 12
Weeks 0, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 056099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unidentified study data can be requested for sharing within reason.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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