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The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316429
Recruitment Status : Active, not recruiting
First Posted : March 20, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
VALENTINE NJIKE, Griffin Hospital

Brief Summary:

Purpose To assess the impact of inclusion of 2 eggs daily for 6 weeks in an otherwise vegan diet compared to a vegan diet on cardio-metabolic risk and dietary pattern in adults at risk for type 2 diabetes.

Hypotheses In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve or have neutral effects on endothelial function and other markers of cardio-metabolic risk in adults at risk for type 2 diabetes.

(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.

(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Cardiovascular Diseases Other: Egg included vegan phase Other: Vegan Phase Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: To provide a sound basis for the statistical comparison of outcome measures for treatment assignments, participants will be randomized to 1 of 2 sequence permutations of an egg-included vegan diet and a vegan diet, which will begin after a 4-week run in phase. Each permutation will include a 6-week treatment phase, followed by a 4-week washout phase, followed by 6-week treatment phase (20 weeks total for each study participant, including the run-in phase).
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Consumption of Eggs in the Context of Plant-Based Diets on
Actual Study Start Date : June 9, 2020
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Egg phase:
Participants will meet with a registered dietitian and receive instructions to include 2 eggs per day for 6 weeks as part of their otherwise vegan diets.
Other: Egg included vegan phase
: Participants will meet with a registered dietitian and receive instructions to include 2 eggs per day for 6 weeks as part of their otherwise vegan diets. Participants will also receive instructions to preserve an isocaloric condition with the addition of 2 eggs in their diets. Counseling of the study participants will be based on the U.S. Department of Agriculture (USDA) healthy vegetarian meal plans, with modifications to exclude dairy products. [21] Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet (with the exception of including eggs) will also be provided.

Placebo Comparator: Control phase:
The participants will consume a vegan diet for 6 weeks.
Other: Vegan Phase
The participants will consume a vegan diet for 6 weeks. The study dietitian will provide counseling and sample meal plans based on the USDA healthy vegetarian dietary pattern, with modifications to exclude eggs and dairy products. Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet will also be provided.




Primary Outcome Measures :
  1. Change in Endothelial Function (EF) Assessment: [ Time Frame: 20 weeks ]
    EF will be assessed at each of the 4 study visits and will be measured noninvasively in the right brachial artery by a high-frequency, 10-15 MHz, vascular ultrasound transducer (Philips iU22, Philips Medical Systems, Bothell, WA) in accordance with published guidelines. Endothelial function will be measured as Flow-mediated dilatation (FMD), that is the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release. In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity. To account for potential variability in stimulus strength, a secondary analysis will be performed in which FMD is divided by flow at 15 seconds post-cuff deflation to create a stimulus-adjusted response measure. All brachial artery reactivity studies (BARS) will be completed prior to noon.


Secondary Outcome Measures :
  1. Change in Diet quality: Automated Self-Administered 24-Hour Recall (ASA24) [ Time Frame: 20 weeks ]
    To assess differences in diet quality and help the study team track any variation in dietary pattern over the course of the study, participants will be asked at each of the 4 assessment visits to provide information on the foods and beverages that they consumed during a 3-day period (i.e., 2 weekdays and 1 weekend day). For each 3-day period, participants will complete 3 consecutive 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, and these data will be reviewed by the study dietitian. Diet quality based on the information provided will be assessed using the Alternative Healthy Eating Index 2015 (AHEI-2015). Intake of micro and macronutrients will also be assessed.

  2. Change in Serum Lipids [ Time Frame: 20 weeks ]
    Blood samples will be collected at the clinical screening and at each of the 4 study visits. Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by direct measurements from the participants' serum of their collected blood samples. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). HDL:Tchol ratio will also be computed.

  3. Change in Body composition [ Time Frame: 20 weeks ]
    Body composition will be measured at the clinical screening and at each of the 4 study visits using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. TheTanita SC-240 Body Composition Analyzer will be used to measure body composition. The SC-240 Body Composition Analyzer measures weight and calculates body fat%, visceral fat rating and total body water% in addition to BMI. In a multicenter European study by Deurenberg et al. [23] with adults between the ages of 18 and 70 years, the use of an impedance-based prediction equation for body fat percentage (which is the basis for the Tanita SC-240 Body Composition Analyzer function) when compared to either dual-energy X-ray absorptiometry (DXA) or densitometry (underwater weighing) - two current standards used to measure body composition - was found to provide good estimates of body fat percentage.

  4. Change in Body weight [ Time Frame: 20 weeks ]
    Body weight will be measured at clinical screening and at each of the 4 study visits Body weight 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.

  5. Waist circumference [ Time Frame: 20 weeks ]
    Waist circumference will be measured at clinical screening and at each of the 4 study visits using the U.S. government standard protocol at each visit. To measure the waist circumference, the clinical research coordinator will ask the participant to stand and will place a measurement tape around the participant's middle, just above her/his hipbones, at the level of the belly button. The clinical research coordinator will ensure that the tape is horizontal around the participant's waist, and will then keep the tape snug around the participant's waist while not compressing the skin, and will measure her/his waist just after exhaling.

  6. Insulin Sensitivity [ Time Frame: 20 weeks ]
    Glucose and insulin will be measured from serum of the blood samples collected at clinical screening (glucose only) and each of the 4 study visits. Participants will be instructed to fast at least 8 hours before glucose and insulin blood draw. To assess insulin sensitivity, insulin resistance (HOMA-IR) will be calculated using values of the participants fasting glucose and insulin.

  7. Office Blood Pressure [ Time Frame: 20 weeks ]
    Systolic and diastolic BP will be measured at the clinical screening and at each of the 4 study visits using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes. Both systolic and diastolic pressures will be calculated as the mean value of 2 readings 5 minutes apart for each participant at every time point of assessment.

  8. Change in Physical Activity [ Time Frame: 20 weeks ]
    Physical activity will be determined by the Seven-Day Physical Activity Recall [PAR]. [23] 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. [24, 25] While it requires considerable cognitive effort by the participants, the interviewer administered version can be completed in a reasonable amount of time (~20 minutes)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) Male, 25-75 years or postmenopausal female 2) Non-smoker; 3) At risk for T2DM as defined by meeting at least one of the criteria listed:

    1. Metabolic syndrome, i.e. meet three out of five of the following criteria:

      1. blood pressure >130/85 mmHg or currently taking antihypertensive medication;
      2. fasting plasma glucose (FPG) >100 mg/dL (6.1 mmol/L);
      3. serum triglycerides level (TG)>150 mg/dL (1.69 mmol/L);
      4. high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1.04 mmol/L) in men, and < 50 mg/dL (1.29 mmol/L) in women;
      5. overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.
    2. Fasting blood glucose >100mg/dL and <126mg/dL or hemoglobin A1C 5.7-6.4 %.

Exclusion Criteria:

  • 1) Allergy to eggs; 2) Anticipated inability to complete the study protocol for any reason; 3) Current eating disorder; 4) Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning; 5) Regular use of high doses of vitamin E (>400IU/day) or vitamin C (>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and/or fiber supplement, unless willing to discontinue supplementation for the study duration; 6) Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators); 7) Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment; 8) Diagnosed diabetes; 9) Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months 10) Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis); 11) Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation; 12) Substance abuse (chronic alcoholism, other chemical dependency); 13) Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder); 14) For women: Use of hormone replacement therapy

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): NCT04316429


Locations
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United States, Connecticut
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
Investigators
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Principal Investigator: Valentine Yanchou Njike, MD, MPH Yale-Griffin Prevention Reserach Center
Publications:
Centers for Disease Control and Prevention. National Diabetes Statistics Report 2017. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
National Institutes of Health, Digestive and Kidney Diseases. Statistics Related to Overweight and Obesity: The Economic Costs. Available from: www.niddk.nih.gov/health/nutrit/pubs/statobes.htm#econ . Accessed 05/16/2019
Centers for Disease Control and Prevention. Available from: http://www.cdc.gov/diabetes/basics/prevention.html . Accessed 05/16/2019
National Institutes of Health, Digestive and Kidney Diseases. Digestive and Kidney Diseases. Available from: https://www.niddk.nih.gov/health-information/diabetes/types/prediabetes-insulin-resistance . Accessed 05/16/2019
Centers for Disease Control and Prevention. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011. Available from: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf . Accessed 05/16/2019
United States Department of Agriculture (USDA). USDA Food Patterns: Healthy Vegetarian Eating Pattern. 2015; Available from: https://health.gov/dietaryguidelines/2015/guidelines/appendix-5 . Accessed 08/15/2019

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Responsible Party: VALENTINE NJIKE, PRINCIPAL INVESTIGATOR, Griffin Hospital
ClinicalTrials.gov Identifier: NCT04316429    
Other Study ID Numbers: 2019-09
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD plan unknown at the moment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases