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Benefits of Eggs in Combination With a Plant-based Diet

Primary Purpose

Coronary Artery Disease, Diabetes, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consume 2 eggs with spinach per day
Egg Subsitute with spinach per day
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring eggs, lutein, zeaxanthin, choline, metabolic syndrome, plant-based diet

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All genders
  • 35-70 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, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women)
  • Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each
  • Willing to follow a plant-based diet for 13 weeks
  • Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease
  • Proficient in English

Exclusion Criteria:

  • Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer
  • Taking glucose lowering medications
  • Triglycerides > 500 mg/dL
  • Cholesterol > 240 mg/dL
  • Blood pressure > 145/100 mm Hg
  • Allergic to eggs or spinach

Sites / Locations

  • Department of Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Egg intake

Egg Subsitute

Arm Description

Consumption of 2 eggs with spinach daily for breakfast for 4 weeks

Consumption of 2 egg substitutes daily for breakfast for 4 weeks

Outcomes

Primary Outcome Measures

Plasma lutein
Plasma lutien will be measured by HPLC. The units are expresses as µmol/L
Plasma choline
It will be measured by mass spectometry. The units are expressed as nmol/mL
Plasma Zeaxanthin
Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L

Secondary Outcome Measures

Plasma lipids
Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL
Plasma glucose
Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL

Full Information

First Posted
January 13, 2020
Last Updated
November 1, 2022
Sponsor
University of Connecticut
Collaborators
American Egg Board
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1. Study Identification

Unique Protocol Identification Number
NCT04234334
Brief Title
Benefits of Eggs in Combination With a Plant-based Diet
Official Title
Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
American Egg Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.
Detailed Description
Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS). Choline is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin. Therefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes, Metabolic Syndrome
Keywords
eggs, lutein, zeaxanthin, choline, metabolic syndrome, plant-based diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Crossover design
Masking
Participant
Masking Description
Egg or Egg substitutes (whites only) will be provided to subjects and since they are similar in appearance and color, they will not know when they are consuming them
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg intake
Arm Type
Experimental
Arm Description
Consumption of 2 eggs with spinach daily for breakfast for 4 weeks
Arm Title
Egg Subsitute
Arm Type
Experimental
Arm Description
Consumption of 2 egg substitutes daily for breakfast for 4 weeks
Intervention Type
Other
Intervention Name(s)
Consume 2 eggs with spinach per day
Other Intervention Name(s)
Egg substitute
Intervention Description
Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment
Intervention Type
Other
Intervention Name(s)
Egg Subsitute with spinach per day
Intervention Description
Egg Subsitute with spinach per day
Primary Outcome Measure Information:
Title
Plasma lutein
Description
Plasma lutien will be measured by HPLC. The units are expresses as µmol/L
Time Frame
1 year
Title
Plasma choline
Description
It will be measured by mass spectometry. The units are expressed as nmol/mL
Time Frame
1 year
Title
Plasma Zeaxanthin
Description
Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Plasma lipids
Description
Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL
Time Frame
1 year
Title
Plasma glucose
Description
Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All genders 35-70 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, blood pressure > 135/85 mm Hg, fasting glucose > 100 mg/dL and HDL < 40 mg/dL for men and < 50 mg/dL for women) Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each Willing to follow a plant-based diet for 13 weeks Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease Proficient in English Exclusion Criteria: Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer Taking glucose lowering medications Triglycerides > 500 mg/dL Cholesterol > 240 mg/dL Blood pressure > 145/100 mm Hg Allergic to eggs or spinach
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Luz Fernandez, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutritional Sciences
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Benefits of Eggs in Combination With a Plant-based Diet

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