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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04673721
Other study ID # Pro00105996
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2021
Est. completion date December 13, 2022

Study information

Verified date January 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 13, 2022
Est. primary completion date December 13, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - = 50 years of age AND - At least one of the following two criteria: - Prior cardiovascular event (myocardial infarction, coronary revascularization or ischemic stroke) OR - 2 cardiovascular risk factors including: 1) Diabetes mellitus (Defined as taking a medication for diabetes OR HgbA1c =6.5% within the prior 18 months; patients with diabetes may be treated with medications that are not associated with hypoglycemia such as metformin, thiazolidinediones (TZDs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium glucose co-transporter 2 (SGLT2) inhibitors and/or dipeptidyl peptidase-4 (DPP-4) inhibitors, 2) Body mass index (BMI) = 30 kg/m2, 3) Hypertension (Defined as taking blood pressure lowering medications OR systolic BP > 140mmHg at screening OR diastolic BP > 90mmHg at screening), 4) Dyslipidemia (Defined as taking lipid lowering medication OR LDL =130 OR HDL <50 for women OR HDL <40 for men OR triglycerides =150), or 5) Chronic kidney disease (Defined as eGFR <60 on most recent laboratory assessment within prior 18 months) - Signed informed consent Exclusion Criteria: - Known allergy or intolerance to eggs - Patients with diabetes who are on insulin or insulin secretagogues (e.g., sulfonylureas and meglitinides) - Recent cardiovascular event (MI, stroke, HF hospitalization) within the past 30 days - Planned initiation/change in lipid therapy within the next 4 months - Current daily use of any supplements or multivitamins containing Vitamin B2 (riboflavin), Vitamin B12, Vitamin D, Vitamin E, or selenium or planned initiation within the next 4 months (current users need a 1-month washout period off supplement prior to eligibility) - Inability or unwillingness to comply with the study requirements - History of heart transplant or left ventricular assist device - Pregnant or nursing women - Malignancy or other non-cardiac condition limiting life expectancy to <4 months - Consumption of > 2 eggs per week (this does not include eggs contained within other foods) - Ongoing or recent (prior 30 days) participation in another interventional study

Study Design


Intervention

Dietary Supplement:
Fortified eggs
Average 12 eggs consumed per week
Behavioral:
Intermittent fasting
16-hour fast and then an 8-hour nutritional window with aim for energy needs to be consumed during an 8 hour eating window (e.g., 11 am - 7 pm) with fasting for 16 hours (e.g., 7 pm - 11 am the next day).
Dietary Supplement:
Non-egg supplemented
2 or less eggs consumed per week
Behavioral:
Usual care diet
Consistency with current diet without consideration of intermittent fasting

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Eggland's Best

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in weight Baseline, 4 months
Other Change in blood pressure Both systolic and diastolic blood pressure will be assessed Baseline, 4 months
Other Change in Dietary intake (2005-Block Questionnaire) Baseline, 4 months
Other Change in microbiome profile Baseline through 4 months
Primary Change in LDL-cholesterol Baseline, 4 months
Primary Change in HDL-cholesterol Baseline, 4 months
Secondary Change in total cholesterol Baseline, 4 months
Secondary Change in triglycerides Baseline, 4 months
Secondary Change in NMP LipoProfile Baseline, 4 months
Secondary Change in lipoprotein subfractionation Baseline, 4 months
Secondary Change in apolipoprotein B Baseline, 4 months
Secondary Change in fatty acid profile Baseline, 4 months
Secondary Change in Vitamin B2 level Baseline, 4 months
Secondary Change in Vitamin B12 level Baseline, 4 months
Secondary Change in Vitamin D level Baseline, 4 months
Secondary Change in Vitamin E level Baseline, 4 months
Secondary Change in selenium level Baseline, 4 months
Secondary Change in high-sensitivity troponin (hsTroponin) Baseline, 4 months
Secondary Change in high-sensitivity c-reactive protein (hsCRP) Baseline, 4 months
Secondary Change in hemoglobin A1c (HbA1c) Baseline, 4 months
Secondary Change in insulin resistance score (LP-IR) Baseline, 4 months
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