PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

Obesity Clinical Trial

— PROSPERITY  

Official title:

PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673721
• Other study ID #: Pro00105996
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Avitaminosis
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias
• Obesity
• Vitamin Deficiency

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