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临床试验/NCT02813031
NCT02813031已完成不适用

Nutritional Intervention Study to Evaluate the Effect of an Olive Oil Lipid Rich in Diglycerides as a Fat Replacement in Different Meat Products, in a Healthy Population

IMDEA Food2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
Changes in waist circumference

研究概览

简要总结

Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people

详细描述

Different studies have revealed that many chronic pathologies including cardiovascular disease, diabetes, autoimmune disorders, cancer, obesity or neurological diseases, could be influenced by different dietary components, such as lipids. Thus, looking for ways to substitute healthier lipids for fats that contain high amounts of cholesterol, saturated fatty acids or trans fat, could be of great interest in the prevention of chronic diseases.

Currently, meat and meat products, especially those where the fat is one of the main ingredients of the formulation, are perceived as unhealthy foods associated with increased risk of cardiovascular disease, cancer and obesity development. This is mainly due to their content of fat, trans fat, high percentage of saturated fatty acids, and cholesterol. Examples include sausages, meat spreads, salami or mortadella. Interestingly, despite the negative perception, meat and meat products continue to hold a relevant position in the diet of the developed countries. Indeed, the group "meat, poultry, deli meats and offal" contribute to the 17% of the total dietary fat intake of the Spanish population. Moreover, the consumption of deli meats and other meat products represents 5.8% of the total caloric intake. These values support the increased interest in evaluating the effect of improving the composition of these products in the prevention of disease.

Overweight and obesity are main public health concerns worldwide. They both contribute to the development of numerous diseases increasing the morbidity and mortality rates of the adult population. In this context, it is suggested that the incorporation of healthier fats may be of great interest in the prevention of these conditions. Thus, usage of lipids from olive oil as fats replacements in meat products could be an interesting strategy for the prevention and treatment of overweight and obesity.

A randomized, controlled, nutritional intervention is proposed to evaluate the effect of functional meat products on body composition and lipid profile in healthy individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women between 18 - 65 years old.
  • BMI >20<27
  • Adequate education level and comprehension of the clinical study.
  • Willingness to participate in the study as a volunteer and to provide written consent.

排除标准

  • Diagnosis of Type I Diabetes .
  • Dyslipidemia under pharmacological treatment.
  • High blood pressure.
  • Dementia, neurological disease or reduction of cognitive function.
  • Severe illness (hepatic disease, renal disease, etc.).
  • Refusal to consume the experimental or control meat products (e.g. Vegetarians)
  • Refusal to follow healthy eating guidelines.
  • Taking medications that could affect the lipid and glycemic profiles (statins, fibrate, diuretics, corticoids, anti-inflammatory, hypoglucemic or insulin) 30 days before the beginning of the study.
  • Taking medications or substances for weight loss management (15 days before the beginning of the study).
  • Consideration to follow a weight loss diet during the duration of the study.
  • Pregnancy or lactation.
  • High intake of alcohol.
  • Any other exclusion criteria that the main investigator considers relevant.

结局指标

主要结局

Changes in waist circumference

时间窗: Before and after 8 weeks

The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).

次要结局

  • Changes in lipid profile(Before and after 8 weeks)
  • Changes in fat depots(Before and after 8 weeks)
  • Changes in blood clotting and endothelial function(Before and after 8 weeks)
  • Product safety(Before and after 8 weeks)

研究者

发起方
IMDEA Food
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviana Loria Kohen

Senior Researcher, Nutrition PhD in Medicine

IMDEA Food

研究点 (2)

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