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临床试验/NCT03420989
NCT03420989已完成不适用

Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome

Endocrinology and Clinical Nutrition Research Center, Spain2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月18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
60
试验地点
2
主要终点
Lipoproteins

研究概览

简要总结

It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.

详细描述

The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.

All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose * insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • presence of metabolic syndrome by (Adult Treatment Panel III) criteria

排除标准

  • consume supplements (vitamins, minerals or other dietary components),
  • non-restrictive diet
  • known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
  • active cancer

结局指标

主要结局

Lipoproteins

时间窗: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks

change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)

次要结局

  • Blood pressure(change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks)
  • carbohydrate metabolism(change from baseline HOMA-Insulin Resistance (units) at 8 weeks)

研究者

发起方
Endocrinology and Clinical Nutrition Research Center, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel de Luis Roman

Medical Doctor

Endocrinology and Clinical Nutrition Research Center, Spain

研究点 (2)

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