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Egg Intake, Metabolic Outcomes and Choline Levels

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06687122
Enrollment
20
Registered
2024-11-13
Start date
2025-01-24
Completion date
2026-12-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Eggs, Liver health, Obesity, Metabolism, Gut microbiome

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENT3 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.

Sponsors

University of Guelph
Lead SponsorOTHER
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Concentration of circulating glucose markersWeeks 0, 4, 8 and 12
Body mass index in kg/m^2Weeks 0, 4, 8 and 12
Body circumference in metricsWeeks 0, 4, 8 and 12
Liver physical density by imaging technologiesWeeks 0, 4, 8 and 12
Liver morphology as assessed by imaging technologiesWeeks 0, 4, 8 and 12
Concentration of circulating liver enzymesWeeks 0, 4, 8 and 12
Concentration of circulating lipid markersWeeks 0, 4, 8 and 12

Secondary

MeasureTime frame
Choline metabolite responseWeeks 0, 4, 8 and 12
Trimethylamine-N-oxide metabolite responseWeeks 0, 4, 8 and 12
Flavin monooxygenase 3 (FMO3) 472 G>A genetic polymorphismWeek 0
Composition of fecal microbiotaWeeks 0, 4, 8 and 12

Countries

Canada

Contacts

CONTACTClara E. Cho, PhD
claracho@uoguelph.ca(519) 824-4120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026