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Obesity and Obesity-related Medical ConditionsNCT06687122

Egg Intake, Metabolic Outcomes and Choline Levels

A study testing 3 whole eggs in people with Obesity and Obesity-related Medical Conditions, run by University of Guelph at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
What is being tested?
3 whole eggs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
24 Jan 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clara E. Cho, PhD contact

(519) 824-4120 ext. 53743

claracho@uoguelph.ca

Canada1 site, 1 recruiting

  • Research Center of the Institut universitaire de cardiologie et de pneumologie de Québec - ULaval

    Québec, Quebec, G1V 4G5

    Éric Paradis, PhD, (418) 656-8711 ext. 5254, eric.paradis@criucpq.ulaval.ca

    Mathieu C. Morissette, PhD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
3 whole eggs
Keywords
Eggs, Liver health, Obesity, Metabolism, Gut microbiome
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 whole eggsDietary supplement

    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.

Study groups in NCT06687122
Study groupRoleWhat they receive
4 weeks of additional daily intake of 3 whole eggsExperimentalNo 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)
Receives: Dietary Supplement: 3 whole eggs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver physical density by imaging technologies

    Measured: Weeks 0, 4, 8 and 12

  2. Liver morphology as assessed by imaging technologies

    Measured: Weeks 0, 4, 8 and 12

  3. Concentration of circulating liver enzymes

    Measured: Weeks 0, 4, 8 and 12

  4. Concentration of circulating lipid markers

    Measured: Weeks 0, 4, 8 and 12

  5. Concentration of circulating glucose markers

    Measured: Weeks 0, 4, 8 and 12

  6. Body mass index in kg/m^2

    Measured: Weeks 0, 4, 8 and 12

  7. Body circumference in metrics

    Measured: Weeks 0, 4, 8 and 12

Secondary outcomes (4)

  1. Choline metabolite response

    Measured: Weeks 0, 4, 8 and 12

  2. Trimethylamine-N-oxide metabolite response

    Measured: Weeks 0, 4, 8 and 12

  3. Flavin monooxygenase 3 (FMO3) 472 G>A genetic polymorphism

    Measured: Week 0

  4. Composition of fecal microbiota

    Measured: Weeks 0, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start24 Jan 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687122
Sponsor's protocol ID
056099
Status last verified
May 2026
First submitted
10 Nov 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Unidentified study data can be requested for sharing within reason.

Publications

  • Noga AA, Zhao Y, Vance DE. An unexpected requirement for phosphatidylethanolamine N-methyltransferase in the secretion of very low density lipoproteins. J Biol Chem. 2002 Nov 1;277(44):42358-65. doi: 10.1074/jbc.M204542200. Epub 2002 Aug 21.

    PubMed 12193594

  • Hebbard L, George J. Animal models of nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol. 2011 Jan;8(1):35-44. doi: 10.1038/nrgastro.2010.191. Epub 2010 Nov 30.

    PubMed 21119613

  • Zeisel SH, Da Costa KA, Franklin PD, Alexander EA, Lamont JT, Sheard NF, Beiser A. Choline, an essential nutrient for humans. FASEB J. 1991 Apr;5(7):2093-8.

    PubMed 2010061

  • Divella R, Mazzocca A, Daniele A, Sabba C, Paradiso A. Obesity, Nonalcoholic Fatty Liver Disease and Adipocytokines Network in Promotion of Cancer. Int J Biol Sci. 2019 Jan 1;15(3):610-616. doi: 10.7150/ijbs.29599. eCollection 2019.

    PubMed 30745847

  • Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.

    PubMed 21475195

  • Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.

    PubMed 23614584

  • Cho CE, Taesuwan S, Malysheva OV, Bender E, Tulchinsky NF, Yan J, Sutter JL, Caudill MA. Trimethylamine-N-oxide (TMAO) response to animal source foods varies among healthy young men and is influenced by their gut microbiota composition: A randomized controlled trial. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600324. Epub 2016 Aug 3.

    PubMed 27377678

  • Cho CE, Aardema NDJ, Bunnell ML, Larson DP, Aguilar SS, Bergeson JR, Malysheva OV, Caudill MA, Lefevre M. Effect of Choline Forms and Gut Microbiota Composition on Trimethylamine-N-Oxide Response in Healthy Men. Nutrients. 2020 Jul 25;12(8):2220. doi: 10.3390/nu12082220.

    PubMed 32722424

Questions about this trial

What is this clinical trial studying?

A study testing 3 whole eggs in people with Obesity and Obesity-related Medical Conditions, run by University of Guelph at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clara E. Cho, PhD ((519) 824-4120 ext. 53743, claracho@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver physical density by imaging technologies (time frame: Weeks 0, 4, 8 and 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06687122, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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