Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Egg albumin-derived peptide

• Registration Number: NCT02223169
• Lead Sponsor: University College Cork

Brief Summary

Heart disease and stroke are the most common cause of death in Ireland today.One of the main risk factors for heart disease and stroke is high blood pressure or hypertension. Research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. The aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.

Detailed Description

Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and metabolic disorders such as type II diabetes leading to a substantial predicted increase in the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major contributing factor to the development of cardiovascular and metabolic diseases. Dietary factors play a significant role in the prevention and/or treatment of hypertension and therefore the development of foods with antihypertensive properties could prove beneficial.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Male and female
• Non-diabetic
• Aged 50-65
• BMI 25-35kg/m²
• Mild hypertensive: Blood pressure 130-149 mmHg

Exclusion Criteria

• Current smoker
• Diagnosed hypertensive
• History of cardiovascular disease
• Diabetic
• Chronic kidney disease
• Gastrointestinal disease
• Currently on anti-hypertensive medications
• Allergic to eggs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Egg albumin-derived peptide	Participants will consume one sachet of the placebo mixed with a fruit juice drink that will appear and taste similar to the albumin derived peptide sachet.
Egg albumin-derived peptide	Egg albumin-derived peptide	Each participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days.

Primary Outcome Measures

Name	Time	Method
A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.	42 days

Trial Locations

Locations (2)

School of Food and Nutritional Sciences, UCC; 🇮🇪 Cork, Ireland

University College Cork; 🇮🇪 Cork, Ireland