An interventional study of 3 whole eggs in Obesity and Obesity-related Medical Conditions, sponsored by University of Guelph. Recruiting at 1 site in Canada. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University of Guelph · Not applicable, Interventional, and Basic science
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 20 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Guelph is the lead sponsor of 70 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Liver physical density by imaging technologies
Time frame: Weeks 0, 4, 8 and 12
Liver morphology as assessed by imaging technologies
Time frame: Weeks 0, 4, 8 and 12
Concentration of circulating liver enzymes
Time frame: Weeks 0, 4, 8 and 12
Concentration of circulating lipid markers
Time frame: Weeks 0, 4, 8 and 12
Concentration of circulating glucose markers
Time frame: Weeks 0, 4, 8 and 12
Body mass index in kg/m^2
Time frame: Weeks 0, 4, 8 and 12
Body circumference in metrics
Time frame: Weeks 0, 4, 8 and 12
Choline metabolite response
Time frame: Weeks 0, 4, 8 and 12
Trimethylamine-N-oxide metabolite response
Time frame: Weeks 0, 4, 8 and 12
Flavin monooxygenase 3 (FMO3) 472 G>A genetic polymorphism
Time frame: Week 0
Composition of fecal microbiota
Time frame: Weeks 0, 4, 8 and 12
Plan to share: No — Unidentified study data can be requested for sharing within reason.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 23 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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University of Guelph