Egg Intake, Metabolic Outcomes and Choline Levels

NCT06687122 | Recruiting

• 1 other identifier: 056099
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Eggs; Liver health; Obesity; Metabolism; Gut microbiome

Outcome Measures

Primary Outcomes (7)

• Liver physical density by imaging technologies

  Weeks 0, 4, 8 and 12

• Liver morphology as assessed by imaging technologies

  Weeks 0, 4, 8 and 12

• Concentration of circulating liver enzymes

  Weeks 0, 4, 8 and 12

• Concentration of circulating lipid markers

  Weeks 0, 4, 8 and 12

• Concentration of circulating glucose markers

  Weeks 0, 4, 8 and 12

• Body mass index in kg/m^2

  Weeks 0, 4, 8 and 12

• Body circumference in metrics

  Weeks 0, 4, 8 and 12

Secondary Outcomes (4)

• Choline metabolite response

  Weeks 0, 4, 8 and 12

• Trimethylamine-N-oxide metabolite response

  Weeks 0, 4, 8 and 12

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

  Week 0

• Composition of fecal microbiota

  Weeks 0, 4, 8 and 12

Study Arms (1)

4 weeks of additional daily intake of 3 whole eggs

EXPERIMENTAL

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

Interventions

3 whole eggs DIETARY_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.

4 weeks of additional daily intake of 3 whole eggs

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 12193594 BACKGROUND

• 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.

  PMID: 21119613 BACKGROUND

• 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.

  PMID: 2010061 BACKGROUND

• 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.

  PMID: 30745847 BACKGROUND

• 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.

  PMID: 21475195 BACKGROUND

• 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.

  PMID: 23614584 BACKGROUND

• 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.

  PMID: 27377678 BACKGROUND

• 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.

  PMID: 32722424 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clara E. Cho, PhD

CONTACT

(519) 824-4120; claracho@uoguelph.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 13, 2024
• Study Start: January 24, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)