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| Name | Class |
|---|---|
| Eggland's Best | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortified eggs + Intermittent fasting | Active Comparator | Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window. |
|
| Non-egg supplemented diet + Intermittent fasting | Active Comparator | Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window. |
|
| Fortified eggs + Usual care diet | Active Comparator | Consume at least 12 fortified eggs per week with consistency with current diet. |
|
| Non-egg supplemented diet + Usual care diet | Placebo Comparator | Maintain consumption of 2 or less eggs per week with consistency with current diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified eggs | Dietary Supplement | Average 12 eggs consumed per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-cholesterol | Baseline, 4 months | |
| Change in HDL-cholesterol | Baseline, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total cholesterol | Baseline, 4 months | |
| Change in triglycerides | Baseline, 4 months | |
| Change in NMP LipoProfile |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Baseline, 4 months | |
| Change in blood pressure | Both systolic and diastolic blood pressure will be assessed | Baseline, 4 months |
Inclusion Criteria:
≥ 50 years of age AND
At least one of the following two criteria:
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Mentz, MD, FACC, FAHA, FHFSA | Duke Cardiovascular Disease Fellowship | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39414223 | Derived | Nouhravesh N, Harrington J, Aberle LH, Green CL, Voss K, Holdsworth D, Misialek K, Slaugh BT, Wieand M, Yancy WS Jr, Pagidipati N, Mentz RJ. Effects of fortified eggs and time-restricted eating on cardiometabolic health: The prosperity trial. Am Heart J. 2025 Jan;279:27-39. doi: 10.1016/j.ahj.2024.10.005. Epub 2024 Oct 15. |
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| Intermittent fasting | Behavioral | 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). |
|
| Non-egg supplemented | Dietary Supplement | 2 or less eggs consumed per week |
|
| Usual care diet | Behavioral | Consistency with current diet without consideration of intermittent fasting |
|
| Baseline, 4 months |
| Change in lipoprotein subfractionation | Baseline, 4 months |
| Change in apolipoprotein B | Baseline, 4 months |
| Change in fatty acid profile | Baseline, 4 months |
| Change in Vitamin B2 level | Baseline, 4 months |
| Change in Vitamin B12 level | Baseline, 4 months |
| Change in Vitamin D level | Baseline, 4 months |
| Change in Vitamin E level | Baseline, 4 months |
| Change in selenium level | Baseline, 4 months |
| Change in high-sensitivity troponin (hsTroponin) | Baseline, 4 months |
| Change in high-sensitivity c-reactive protein (hsCRP) | Baseline, 4 months |
| Change in hemoglobin A1c (HbA1c) | Baseline, 4 months |
| Change in insulin resistance score (LP-IR) | Baseline, 4 months |
| Change in Dietary intake (2005-Block Questionnaire) | Baseline, 4 months |
| Change in microbiome profile | Baseline through 4 months |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D001361 | Avitaminosis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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