Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk

Hypertension Clinical Trial

— CardiProtein  

Official title:

Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223169
• Other study ID #: ECFP7-312090
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: May 2, 2017
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Egg albumin-derived peptide
Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.

Locations

Country	Name	City	State
Ireland	School of Food and Nutritional Sciences, UCC	Cork
Ireland	University College Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.		42 days