HypertensionCardiProteinNCT02223169
Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk
A study testing Egg albumin-derived peptide in people with Hypertension, run by University College Cork at 2 sites in Ireland.
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… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Egg albumin-derived peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 2 sitesIreland
- Study dates
- Apr 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female
- Non-diabetic
- Aged 50-65
- BMI 25-35kg/m²
- Mild hypertensive: Blood pressure 130-149 mmHg
Who cannot join
- Current smoker
- Diagnosed hypertensive
- History of cardiovascular disease
- Diabetic
- Chronic kidney disease
- Gastrointestinal disease
- Currently on anti-hypertensive medications
- Allergic to eggs
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
School of Food and Nutritional Sciences, UCC
Cork
University College Cork
Cork
About this study
Official title: Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Egg albumin-derived peptide
- Keywords
- Blood Pressure, Hypertension, Cardiovascular disease
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg albumin-derived peptideDietary supplement
Also called Tensio-control
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.
| Study group | Role | What they receive |
|---|---|---|
| Egg albumin-derived peptide | Experimental | Each participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days. Receives: Dietary Supplement: Egg albumin-derived peptide |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Egg albumin-derived peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mairead Kiely PhD, University College Cork
- Investigators
- Mairead Kiely, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223169
- Sponsor's protocol ID
- ECFP7-312090
- Acronym
- CardiProtein
- Status last verified
- May 2017
- First submitted
- 20 Aug 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults
- ClinicalTrials.gov ID
- NCT02223169
- Acronym / sponsor ID
- CardiProtein / ECFP7-312090
- Conditions
- Hypertension
- Keywords
- Blood Pressure, Hypertension, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg albumin-derived peptide | Experimental | Dietary Supplement: Egg albumin-derived peptideEach 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 comparator | Dietary Supplement: Egg albumin-derived peptideParticipants 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female
- Non-diabetic
- Aged 50-65
- BMI 25-35kg/m²
- Mild hypertensive: Blood pressure 130-149 mmHg
Key exclusion criteria (8 listed)
- Current smoker
- Diagnosed hypertensive
- History of cardiovascular disease
- Diabetic
- Chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg albumin-derived peptideAlso: Tensio-controlDouble-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. | Dietary supplement | Egg albumin-derived peptide, Placebo |
Primary outcome
A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mairead Kiely, PhD principal investigator
University College Cork
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg albumin-derived peptide in people with Hypertension, run by University College Cork at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group. (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.