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临床试验/NCT02585089
NCT02585089Unknown不适用

Beneficial Effects of Pork Bioactive Peptides on Cardiovascular Health in Humans

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Change from Baseline in Systolic Blood Pressure at 28 days

研究概览

简要总结

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.

详细描述

A two-arm cross-over clinical study with a diet control will be assessed at the Catholic University of Murcia (UCAM).

A recruitment of 50 volunteers will be attempted in order to fulfil the UCC calculations. The 50 patients will be divided into two groups (25 vs 25). One group will receive dry-cured pork ham of >10 months proteolysis (intervention product) while the other will receive cooked, uncured ham (control product), each for one month. After two weeks wash out, the groups will be exchanged for one additional month. In this way, each group will take cooked ham and dry-cured pork ham for 28 days each arm.

Pork hams Two pork hams from the same raw meat will be used in the present study: dry-cured pork ham with >10 months dry-curing process as the intervention product and cooked, uncured ham as the control product. Both products will be purchased in vacuum bags and labelled with safety information (expiration date, nutritional composition and storage information).

Dry-cured ham with reduced salt will be used in order to decrease the sodium intake that could affect BP too. Such ham contains 25% lower salt than similar products on the market (3,7g vs 4,5g/100g) (see leaflet of a possible ham enclosed).

Dry-cured ham (80g) will be taken daily by the volunteers (50% humidity); BP will be measured as follows. In order to counteract the higher water contain (70% humidity), a higher amount of cooked ham will be given to the control groups (100g). Besides, cooked ham contains 2.5g salt/100g which is in relation with the 2,96g salt/80g reduced salt dry-cured ham. A restriction list food will be also given to the volunteers in order to control salt intake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

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.

干预措施: Spanish cured-pork ham (Other)

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.

干预措施: Cooked pork ham (Other)

结局指标

主要结局

Change from Baseline in Systolic Blood Pressure at 28 days

时间窗: Before/after 28 days of interventional product and placebo product

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

次要结局

未报告次要终点

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

LUIS TEJADA PORTERO

Lecturer

Universidad Católica San Antonio de Murcia

研究点 (1)

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