Assessment of TMAO Formation With Egg Intake Versus Choline Supplement in a Healthy Population

NCT03142763 | Completed DMC

• 1 other identifier: H16-194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the effects of consuming either 3 eggs per day as compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals. The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a different TMAO response when compared to choline in free supplemental form.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Eggs of Egg Consumption on Plasma Biochemical Parameters

  Using plasma form each participant, an automated spectrophotometer is able to analyze at once plasma lipids \[total colesterol, triglycerides, HDL (mg/dL)\], glucose (mg/dL), CRP (mg/dL, and liver enzymes \[alanine aminotransferase and aspartate aminotransferase (U/L)\].

  1 year

Secondary Outcomes (1)

• Effects of Intervention on Gene Expression using RT-PCR

  1 year

Study Arms (2)

Egg intake

EXPERIMENTAL

Consumption of 3 eggs per day for breakfast, 4 weeks

Other: Eggs

Choline Supplement intake

EXPERIMENTAL

Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks

Dietary Supplement: Choline Supplement

Interventions

Eggs OTHER

Consumption of 3 eggs per day for breakfast, 4 weeks

Egg intake

Choline Supplement DIETARY_SUPPLEMENT

Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks

Choline Supplement intake

Eligibility Criteria

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

You may qualify if:

• Men and women (18-30 years), BMI 18.5 - 29.9 kg/m2, proficient in English, and willing to consume 3 eggs per day or 397.5 mg of choline supplement (1½ tablets/day) for 4 weeks each.

You may not qualify if:

• Self-reported diabetes mellitus, cardiovascular disease, history of stroke, renal problems, liver disease, cancer, or a diagnosed eating disorder
• Taking any glucose-lowering prescriptions or supplements, triglyceride-lowering medications, bile acid sequestrants, or high dose chromium or cinnamon supplements
• Taken antibiotics in the previous 1 months, or if they are vegetarian or vegan
• BMI ≤ 18.4 or ≥ 30 kg/m2, or extreme clinical values, such as plasma triglycerides \> 500 mg/dL, plasma glucose \> 126 mg/dL, plasma cholesterol \> 240 mg/dL, plasma creatinine ≤ 0.5 or ≥ 0.9 mg/dL for females and ≤ 0.7 or ≥ 1.2 mg/dL for males, or blood pressure \> 140/90 mm Hg (average of 3 readings)
• Allergic to eggs or any component of the choline supplement

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Interventions

Eggs

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Luz Fernandez, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: January 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)