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Benefits of Eggs in Combination With a Plant-based Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234334
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Maria Luz Fernandez, University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Metabolic Syndrome Other: Consume 2 eggs with spinach per day Other: Egg Subsitute with spinach per day Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Crossover design
Masking: Single (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
Primary Purpose: Prevention
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
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egg intake
Consumption of 2 eggs with spinach daily for breakfast for 4 weeks
Other: Consume 2 eggs with spinach per day
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
Other Name: Egg substitute

Experimental: Egg Subsitute
Consumption of 2 egg substitutes daily for breakfast for 4 weeks
Other: Egg Subsitute with spinach per day
Egg Subsitute with spinach per day




Primary Outcome Measures :
  1. Plasma lutein [ Time Frame: 1 year ]
    Plasma lutien will be measured by HPLC. The units are expresses as µmol/L

  2. Plasma choline [ Time Frame: 1 year ]
    It will be measured by mass spectometry. The units are expressed as nmol/mL

  3. Plasma Zeaxanthin [ Time Frame: 1 year ]
    Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L


Secondary Outcome Measures :
  1. Plasma lipids [ Time Frame: 1 year ]
    Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL

  2. Plasma glucose [ Time Frame: 1 Year ]
    Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234334


Locations
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United States, Connecticut
Department of Nutritional Sciences Recruiting
Storrs, Connecticut, United States, 06269
Contact: Maria-Luz Fernandez, PhD    860-486-5547    maria-luz.fernandez@uconn.edu   
Contact: Minu S Thomas, MS       minu.thomas@uconn.edu   
Sponsors and Collaborators
University of Connecticut
American Egg Board
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Responsible Party: Maria Luz Fernandez, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT04234334    
Other Study ID Numbers: H19-178
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Luz Fernandez, University of Connecticut:
eggs
lutein
zeaxanthin
choline
metabolic syndrome
plant-based diet
Additional relevant MeSH terms:
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Coronary Artery Disease
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases