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Completed

NCT Number: NCT02223169

Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk

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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Food and Nutritional Sciences, UCC, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Egg albumin-derived peptide

Dietary Supplement

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.

Other names: Tensio-control

Primary outcomes

  1. A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

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

Acronym: CardiProtein

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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