NCT04234334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

January 13, 2020

Last Update Submit

November 1, 2022

Conditions

Coronary Artery DiseaseDiabetesMetabolic Syndrome

Keywords

eggsluteinzeaxanthincholinemetabolic syndromeplant-based diet

Outcome Measures

Primary Outcomes (3)

  • Plasma lutein

    Plasma lutien will be measured by HPLC. The units are expresses as µmol/L

    1 year

  • Plasma choline

    It will be measured by mass spectometry. The units are expressed as nmol/mL

    1 year

  • Plasma Zeaxanthin

    Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L

    1 year

Secondary Outcomes (2)

  • Plasma lipids

    1 year

  • Plasma glucose

    1 Year

Study Arms (2)

Egg intake

EXPERIMENTAL

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

Other: Consume 2 eggs with spinach per day

Egg Subsitute

EXPERIMENTAL

Consumption of 2 egg substitutes daily for breakfast for 4 weeks

Other: Egg Subsitute with spinach per day

Interventions

Consume 2 eggs with spinach per dayOTHER

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

Also known as: Egg substitute
Egg intake
Egg Subsitute with spinach per dayOTHER

Egg Subsitute with spinach per day

Egg Subsitute

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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, 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes MellitusMetabolic Syndrome

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Maria-Luz Fernandez, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized Crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 21, 2020

Study Start

January 13, 2020

Primary Completion

March 31, 2022

Study Completion

August 31, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)