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临床试验/NCT05213273
NCT05213273已完成不适用

TUNACAN: Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population

Sara Arranz Martinez2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2021年11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
152
试验地点
2
主要终点
Metabolic status: RBC membrane fatty acid profile.

研究概览

简要总结

There is sufficient evidence on the beneficial effects of fish consumption on health, mainly associated with the content of omega-3 polyunsaturated fatty acids (EPA and DHA) present mainly in blue fish. Different national and international organizations have issued recommendations on the optimal amount of fish that the population should consume to prevent certain chronic diseases related to diet. Thus, the WHO recommends eating fish regularly (1-2 servings per week for healthy adults) to ideally provide the equivalent of 250 mg of omega-3 fatty acids (EPA + DHA). Not reaching the optimal levels of EPA + DHA increases the risk for cardiovascular diseases, increasing the risk of death according to certain epidemiological studies. In this sense, using more precise techniques such as membrane lipidomics, allow adequate quantification and monitoring of fatty acid levels present in our body and how this lipid profile can change according to metabolism and diet. The objective of this study is to carry out a clinical trial of nutritional intervention with an adult population without pathologies that has a low consumption of fish (<2 servings / week) to evaluate the effectiveness of an intervention strategy based on increasing the number of fish servings through a controlled intake of fresh and canned fish.

The results aim to show that increasing fish intake has an impact on lipid metabolism and in the future, for the prevention of certain chronic diseases, the introduction of canned fish can be a healthy strategy to increase fish consumption to long term.

详细描述

Objectives:

The main objective of this study is to demonstrate through a nutritional intervention, the benefits of the intake of canned fish compared to fresh or frozen fish on lipid metabolism in a healthy adult population, which can be divided into three specific objectives:

  • Assessment of the health benefits of consuming canned fish (controlled intake): impact on the fatty acid profile of red blood cell membrane.
  • Provide evidence of the benefits of consuming canned fish compared to intake fresh / frozen fish.
  • Demystify the bad reputation of canned fish products (as processed foods).

Study design:

A prospective, randomized, controlled, parallel-group nutritional intervention clinical trial will be carried out with 150 healthy adults between 18 and 65 years for 4 months. Participants will be randomized into one of the two equal size intervention groups: "group A: fresh/frozed fish" or "group B: canned fish".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Healthy adults (men and women)
  • 18.5 <BMI <24.
  • Individuals who habitually have a lower fish intake1-2 servings/week

排除标准

  • Diagnosed with concomitant diseases or chronic disease.
  • Have been subjected to transplant.
  • Be taking medication
  • Consuming or having consumed omega-3 supplements, vitamins, minerals, prebiotics or probiotics 3 months before starting the study. Food allergies.

结局指标

主要结局

Metabolic status: RBC membrane fatty acid profile.

时间窗: 4 months

Twelve fatty acids will by analyzed as representative cluster of the main building blocks of the red blood cell (RBC) membrane glycerophospholipids (palmitic acid, stearic acid, palmitoleic acid, oleic acid, cis-vaccenic acid, eicosapentaenoic acid, docosahexaenoic acid, linoleic acid, dihomo-gamma-linolenic acid (DGLA), arachidonic acid (AA) and two geometrical trans fatty acids (trans elaidic acid and mono-trans arachidonic acid isomer). The amount of each fatty acid will be calculated as a percentage of the total fatty acid content in the red blood cell membrane (relative %). Omega 3 index (EPA+DHA) as a biomarker of cardiovascular risk and omega-6/omega-3 ratio as biomarker of inflammatory status will be the main outcomes. Investigators will take into accounts the optimal ranges of each of the 12 fatty acids in red blood cell membranes previously reported in the literature (Ferreri C et al. 2012. Expert Rev. Mol. Diagn. 12(7), 767-780).

次要结局

  • Biochemical parameters in plasma(4 months)

研究者

发起方
Sara Arranz Martinez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Arranz Martinez

Senior Researcher

Fundacion Azti

研究点 (2)

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