Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk
CardiProtein
Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults
1 other identifier
interventional
69
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Apr 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 3, 2017
May 1, 2017
1.8 years
August 20, 2014
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.
42 days
Study Arms (2)
Egg albumin-derived peptide
EXPERIMENTALEach participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male and female
- Non-diabetic
- Aged 50-65
- BMI 25-35kg/m²
- Mild hypertensive: Blood pressure 130-149 mmHg
You may not qualify if:
- Current smoker
- Diagnosed hypertensive
- History of cardiovascular disease
- Diabetic
- Chronic kidney disease
- Gastrointestinal disease
- Currently on anti-hypertensive medications
- Allergic to eggs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
School of Food and Nutritional Sciences, UCC
Cork, Ireland
University College Cork
Cork, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mairead Kiely, PhD
University College Cork
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 22, 2014
Study Start
April 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 3, 2017
Record last verified: 2017-05