NCT03272074

Brief Summary

The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 28, 2017

Last Update Submit

August 31, 2017

Conditions

Diabetes Mellitus, Type 2ObesityPre Diabetes

Outcome Measures

Primary Outcomes (1)

  • Fasting blood glucose, insulin resistance, and insulin sensitivity

    Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2

    12 weeks

Secondary Outcomes (1)

  • Lipid panel

    12 weeks

Other Outcomes (2)

  • Body composition

    12 weeks

  • ABCA1 Protein

    12 weeks

Study Arms (2)

Egg Group (Group A)

EXPERIMENTAL

Participants will consume one large egg per day for 12 weeks

Other: Egg and egg white

Egg White Group (Group B)

ACTIVE COMPARATOR

Participants will consume equivalent amounts of egg whites for 12 weeks

Other: Egg and egg white

Interventions

Egg and egg whiteOTHER

Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.

Egg Group (Group A)Egg White Group (Group B)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
  • With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is \>5.6%

You may not qualify if:

  • Subjects with BMI≤ 24 or ≥46 kg/m2
  • Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
  • Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
  • Subjects who are allergic to egg and egg products will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityGlucose Intolerance

Interventions

Egg White

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemia

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shirin Pourafshar, PhD

    Florida State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Margaret A. Sitton Professor, Director of Center for Advancing Exercise and Nutrition Research on Aging

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 5, 2017

Study Start

September 11, 2015

Primary Completion

September 7, 2016

Study Completion

August 5, 2017

Last Updated

September 5, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)