NCT02585089

Brief Summary

Spanish dry-cured ham has been shown a source of antihypertensive peptides in mice. To date, no clinical study has been performed in humans to check the effects of bioactive peptides produced naturally during the processing of pork dry-cured ham on blood pressure. Therefore, the aim of the present study is to investigate whether consuming peptides from cured pork ham with demonstrated angiotensin I-converting enzyme (ACE) inhibitory activity lowers blood pressure (BP) and improves other risk factors for cardiovascular disease (CVD). Objectives: To demonstrate the lowering effects of bioactive peptides from cured pork ham with \>10 months dry-curing process in humans. To check for other possible benefits related to dry-cured ham intake such as: platelet activation and cardiovascular risk factors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 31, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 31, 2015

Last Update Submit

July 25, 2016

Conditions

HypertensionCardiovascular Diseases

Keywords

Hypertensionactive biopeptidecardiovascular pathophysiologyangiotensin converting enzyme inhibitioncured-pork ham

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Systolic Blood Pressure at 28 days

    24h holters (OMROM) will be used for comparing blood pressure during the study

    Before/after 28 days of interventional product and placebo product

Study Arms (2)

Spanish cured-pork ham

ACTIVE COMPARATOR

One group will receive dry-cured pork ham of \>10 months proteolysis (intervention product). Intervention: Dietary intake Dry-cured pork ham contains high doses of bioactive peptides produced during more than 10 months of proteolysis.

Other: Spanish cured-pork ham

Cooked pork ham

PLACEBO COMPARATOR

The other group will receive cooked, uncured ham (placebo product). Intervention: Dietary intake. Cooked ham does not display bioactive peptides as they are produced during proteolysis of pork ham.

Other: Cooked pork ham

Interventions

Spanish cured-pork hamOTHER

Dry-cured ham with reduced salt will be used in order to decrease the sodium intake that could affect blood pressure too. Such ham contains 25% lower salt than similar products on the market (3,7g vs 4,5g/100g). Volunteers will receive 80g of cured pork ham daily for 28 consecutive days. They can eat the interventional product at any time of the day.

Spanish cured-pork ham
Cooked pork hamOTHER

Volunteers will receive 100g of cooked pork ham daily for 28 consecutive days. They can eat the product (placebo product) at any time of the day.

Cooked pork ham

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian men and women,
  • aged 35-60 years in good general health with an average of systolic arterial pressure \>130 mmHg and diastolic \>80 mmHg.

You may not qualify if:

  • smokers,
  • Diabetes mellitus,
  • diagnosed and treated hypertension,
  • history of cardiovascular events (stroke, myocardial infarction or peripheral vascular disease),
  • receiving medications: anti-hypertensives, vasodilators, lipid lowering therapies and fish oil supplements unless willing to discontinue prior to \& during study (all other supplements will be assessed on a case by case basis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia (UCAM)

Murcia, Murcia, 30107, Spain

Location

Related Links

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Pilar Zafrilla, PhD

    UCAM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 31, 2015

First Posted

October 23, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

September 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

ES(1)