NCT04673721已完成不适用
PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in LDL-cholesterol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
结局指标
主要结局
Change in LDL-cholesterol
时间窗: Baseline, 4 months
Change in HDL-cholesterol
时间窗: Baseline, 4 months
次要结局
- Change in Vitamin E level(Baseline, 4 months)
- Change in high-sensitivity troponin (hsTroponin)(Baseline, 4 months)
- Change in total cholesterol(Baseline, 4 months)
- Change in Vitamin D level(Baseline, 4 months)
- Change in triglycerides(Baseline, 4 months)
- Change in lipoprotein subfractionation(Baseline, 4 months)
- Change in selenium level(Baseline, 4 months)
- Change in hemoglobin A1c (HbA1c)(Baseline, 4 months)
- Change in insulin resistance score (LP-IR)(Baseline, 4 months)
- Change in apolipoprotein B(Baseline, 4 months)
- Change in fatty acid profile(Baseline, 4 months)
- Change in high-sensitivity c-reactive protein (hsCRP)(Baseline, 4 months)
- Change in NMP LipoProfile(Baseline, 4 months)
- Change in Vitamin B2 level(Baseline, 4 months)
- Change in Vitamin B12 level(Baseline, 4 months)
研究者
研究点 (2)
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