Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
1 other identifier
interventional
25
1 country
2
Brief Summary
The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Nov 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedNovember 3, 2020
November 1, 2020
1.1 years
March 13, 2019
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plasma choline and TMAO (micromol/L)
They will be measured simultaneously by use of a mass spectrophotometer
1 year
Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
They will be measured simultaneoulsy by use of an automated spectrophotometer
1 year
Secondary Outcomes (1)
Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
1 year
Study Arms (2)
Egg Intake
EXPERIMENTALConsumption of 3 eggs per day for breakfast during 4 weeks
Choline Supplement Intake
EXPERIMENTALConsumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks
Interventions
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Eligibility Criteria
You may qualify if:
- All genders
- years
- Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference \> 88 cm for women and \> 102 cm for men, plasma triglycerides \> 150 mg/dL, fasting glucose \> 100 mg/dL, blood pressure \> 135/85 and HDL \< 40 mg/dL for men and \< 50 mg/dL for women),
- willing to consume 3 eggs per day for 4 weeks
- willing to consume choline supplement (400 mg/day for 4 weeks)
You may not qualify if:
- Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
- Taking glucose lowering medications
- Taking antibiotics in the previous 1 month
- Triglycerides \> 500 mg/dL,
- Cholesterol \> 240 mg/dL,
- blood pressure \> 145/100 mm of Hg
- Allergic to eggs or to choline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Connecticutlead
- American Egg Boardcollaborator
Study Sites (2)
Department of Nutritional Sciences
Storrs, Connecticut, 06269, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 15, 2019
Study Start
November 1, 2018
Primary Completion
December 14, 2019
Study Completion
June 30, 2020
Last Updated
November 3, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share