Obesity Clinical Trial
— PROSPERITYOfficial title:
PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health
Verified date | January 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Eggland's Best |
United States,
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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