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Type 2 DiabetesNCT02052037

Egg Ingestion in Adults With Type 2 Diabetes

A study testing Egg inclusion and Egg exclusion in people with Type 2 Diabetes, run by Griffin Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

We propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with Type 2 diabetes. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Egg inclusion and Egg exclusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Jan 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • males age greater than 35 years;
  • post-menopausal females not currently on hormone replacement therapy;
  • non-smokers;
  • clinical diagnosis of Type 2 diabetes mellitus for at least 1 year but no more than 5 years;
  • 6.5% ≤ HbA1c ≤8.0% (5) BMI between 25 and 40 kg/m².

Who cannot join

  • failure to meet inclusion criteria;
  • anticipated inability to complete study protocol for any reason;
  • current eating disorder;
  • use of antihyperglycemic, lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months;
  • use of glucocorticoids, antineoplastic agents, psychoactive agents, or nutraceuticals;
  • regular use of fiber supplements;
  • restricted diets (i.e., vegetarian, vegan, gluten free);
  • known allergy to eggs.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale-Griffin Prevention Research Center

    Derby, Connecticut, 06418

Other trials in United States

About this study

Official title: Egg Ingestion in Adults With Type 2 Diabetes: Effects on Glycemic Control, Anthropometry, Diet Quality and Cardiometabolic Status A Randomized, Controlled, Crossover Trial

We propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with Type 2 diabetes.

Read the detailed description

Hypothesis Inclusion of eggs in the diets of individuals with Type 2 diabetes mellitus will improve glycemic control, anthropometric measures and overall diet quality.

Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients at increased risk for CVD, including those with diabetes. However, the relative importance of dietary cholesterol to serum lipids and the role of egg ingestion in cardiovascular risk are increasingly suspect. Further, the exclusion of eggs from the diet may lead to increased consumption of high-glycemic carbohydrate foods of particular potential harm to individuals with diabetes. The examination of how food-specific recommendations translate into effects on other food choices and overall diet quality, and in turn health effects, is a neglected area of research.

Eggs provide a complete profile of amino acids and an array of micronutrients, and are low in total fat. Although epidemiological and clinical studies largely suggest a lack of association between egg intake and harmful effects, the evidence is somewhat more ambiguous with regard to glycemic control for diabetes, or the risk for CVD among individuals with diabetes. Our own prior work shows no adverse effects of egg ingestion in healthy adults, hyperlipidemic adults, or adults with established coronary artery disease. As a satiating and protein-rich food, eggs have potential to foster calorie and weight control, and to reduce the dietary glycemic load, offering potential advantages in Type 2 diabetes.

Conditions
Type 2 Diabetes
Being tested
Egg inclusion, Egg exclusion
Keywords
Type 2 Diabetes, Egg, Glycemic Control, Insulin sensitivity, Diet quality
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Egg inclusionDietary supplement

    Participants will meet with a registered dietitian and receive instructions for including 2 eggs per day (10 to 14 eggs/week)in their meal plan, while preserving an isocaloric condition relative to the egg exclusion phase. The study dietitian will provide individualized guidance to participants on how to make room for eggs in their diet, while giving them latitude in determining how to adjust for the extra calories from the eggs, to better approximate real-world conditions. Treatment phase will last for 12 weeks.

  • Egg exclusionDietary supplement

    Participants will meet with the dietitian and receive relevant meal planning guidance and instructions to avoid eggs and specific egg-containing products.

    During both intervention phases, study participants will be advised to eat to their usual state of fullness, and dietary monitoring and weighing will be conducted to ensure that an isocaloric condition is maintained. Treatment phase will last for 12 weeks.

Study groups in NCT02052037
Study groupRoleWhat they receive
Egg inclusionExperimentalParticipants will meet with a registered dietitian and receive instructions for including 2 eggs per day (10 to 14 eggs/week) in their meal plan, while preserving an isocaloric condition relative to the egg exclusion phase. The study dietitian will provide individualized guidance to participants on how to make room for eggs in their diet, while giving them latitude in determining how to adjust for the extra calories from the eggs, to better approximate real-world conditions.
Receives: Dietary Supplement: Egg inclusion
Egg exclusionExperimentalParticipants will meet with the dietitian and receive relevant meal planning guidance and instructions to avoid eggs and specific egg-containing products. During both intervention phases, study participants will be advised to eat to their usual state of fullness, and dietary monitoring and weighing will be conducted to ensure that an isocaloric condition is maintained.
Receives: Dietary Supplement: Egg exclusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic Index

    Glycated hemoglobin A1c (HbA1c) will be used to measure the average plasma glucose concentration.

    Measured: 12-weeks

Secondary outcomes (6)

  1. Fasting glucose and insulin

    Glucose and insulin will be measured at each time point. Participants will be asked to fast at least 8 hours before glucose and insulin measurement. Homeostasis Model Assessment (HOMA-IR) values will be calculated from fasting serum glucose and serum insulin levels using HOMA calculator version 2.2.1 to gauge the degree of insulin resistance.

    Measured: 12-weeks

  2. Body Composition

    Body composition will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Tanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat% and total body water% in addition to BMI.

    Measured: 12- weeks

  3. Body Weight

    Body weight will be measured during each visit. It will be measured to the nearest 0.5 pound using a balance-type medical scale. Subjects will be measured in the morning (fasting), unclothed with the exception of undergarments.

    Measured: 12- weeks

  4. Waist Circumference

    Waist circumference will be measured using the U.S. government standard protocol. It will be measured around the narrowest point between ribs and hips when viewed from the front after exhaling.

    Measured: 12-weeks

  5. Diet Quality

    To help the study team track any variation in dietary pattern over the course of the study, all participants will be asked at two time points to provide information on the foods and beverages that they consumed during a 3-day period. For each 3-day period, participants will complete three 24-hour recalls using a web-based Automated Self-Administered 24-Hour Recall (ASA24) (available from the National Cancer Institute at http://riskfactor.cancer.gov/tools/instruments/asa24/) which will guide them through the process of completing the recall data. Diet quality will be assessed using the Alternative Healthy Eating Index (AHEI). 3-day food period data will be collected at baseline, 6 weeks and 12 weeks.

    Measured: Baseline, 6-weeks, 12-weeks

  6. Physical Activity

    Physical activity will be determined by the Seven-Day Physical Activity Recall [PAR]. The PAR is one of the most widely used physical activity assessments in exercise science and epidemiological research. The popularity of this measure stems largely from its versatility and relative ease of use for research applications. The PAR provides detail regarding the duration, intensity, and volume (energy expenditure) of physical activity and can therefore be used for a variety of applications. Because it utilizes a one-week time frame, the data from the PAR is often considered representative of typical activity patterns. While it requires considerable cognitive effort by the participants, the interviewer administered version can be completed in a reasonable amount of time (~20 minutes). Variation in physical activity level will be controlled in our multivariable regression models.

    Measured: 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052037
Sponsor's protocol ID
2013-05
Status last verified
Nov 2017
First submitted
29 Jan 2014
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Njike VY, Annam R, Costales VC, Yarandi N, Katz DL. Which foods are displaced in the diets of adults with type 2 diabetes with the inclusion of eggs in their diets? A randomized, controlled, crossover trial. BMJ Open Diabetes Res Care. 2017 Jul 13;5(1):e000411. doi: 10.1136/bmjdrc-2017-000411. eCollection 2017.

    PubMed 28761662

  • Njike VY, Ayettey RG, Rajebi H, Treu JA, Katz DL. Egg ingestion in adults with type 2 diabetes: effects on glycemic control, anthropometry, and diet quality-a randomized, controlled, crossover trial. BMJ Open Diabetes Res Care. 2016 Dec 22;4(1):e000281. doi: 10.1136/bmjdrc-2016-000281. eCollection 2016.

    PubMed 28074139

Questions about this trial

What is this clinical trial studying?

A study testing Egg inclusion and Egg exclusion in people with Type 2 Diabetes, run by Griffin Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Index (time frame: 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02052037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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