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临床试验/NCT01264523
NCT01264523已完成不适用

Short-term Effect of the Intake of Moderately High-protein, Low-glycemic Load Products on Anthropometrical, Glucose Metabolism and Lipid Metabolism Biomarkers, in Type-2 Diabetes Patients

Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年9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
17
试验地点
2
主要终点
Total Body weight

研究概览

简要总结

The main objective of this study is to evaluate the effects on anthropometric, glucose metabolism and lipid profile biomarkers of exchanging with high-protein, low-glycemic index products (40-30-30) the habitual breakfast, mid-morning and afternoon snacks on type-2 diabetes patients following a chronologically scheduled pattern.

详细描述

Type 2 diabetes prevalence in adults has grown in the last years in many societies, accompanying the high incidence of obesity-related and other cardiovascular risk factors. Indeed, obesity is the most relevant overnutrition disease worldwide, being more dramatic than a self-esteem problem or an aesthetic issue, since it is associated to different metabolic disorders such as coronary diseases, hypertension, certain tumors, dislipidemia, biliary disorders, immunodeficiencies and insulin resistance. Different studies have shown the efficacy of low-fat diets on weight reduction, which has been associated to an improvement in overweight-related chronic pathological conditions. Additionally, a moderate increase of protein content (up to 30% of total caloric intake) in the diet and the inclusion of low-glycemic index products have been shown as a good tool for weight loss and maintenance. Recent studies have also shown the benefits of partial nutritional interventions, mainly on modifying breakfast intake, on anthropometrical and cardiovascular risk factors in overweight patients.

The study has been designed as a longitudinal nutritional intervention with two consecutive 4-week periods: from week 0 to 4, volunteers will follow their habitual diet. The second period (week 4 to 8), the volunteers' habitual breakfast, mid-morning and afternoon snacks will be substituted by 40-30-30 products, without changing any other parameter of their habitual diet or lifestyle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed of type-2 Diabetes
  • Under dietary treatment or with Metformin
  • Body Mass Index (BMI) Between 22 and 35 kg/m2

排除标准

  • BMI under 22 or over 35 kg/m2
  • To follow a pharmacological treatment with other drugs but metformin
  • To be already insulin-dependent
  • To have other concomitant pharmacological treatments for weight loss, hormonal substitutive therapy, altered thyroid function, etc. without an stable dosage (at least three months prior the beginning of the study).
  • To suffer from complications due to type 2 diabetes (microangiopathy, polyneuropathy, cardiopathy, hepatic and renal impairments, etc)
  • To have a recent (less than 3 months before the beginning of the study) uncontrolled diagnostic of hypercholesterolemia and/or hypertriglyceridemia.

结局指标

主要结局

Total Body weight

时间窗: weeks 0, 4 and 8

Total body weight will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

Fat Mass

时间窗: weeks 0, 4 and 8

Fat Mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

Fat-free mass

时间窗: weeks 0, 4 and 8

Fat-free mass will be measured at the beginning of the study (week 0), at week 4 (before starting the intervention with 40-30-30 products) and week 8 (end of the study).

次要结局

  • Hip circumference(weeks 0, 4 and 8)
  • Waist circumference(weeks 0, 4 and 8)
  • Basal glucose concentration(weeks 0, 4 and 8)
  • Basal Insulin Concentration(weeks 0, 4 and 8)
  • HOMA-IR index(weeks 0, 4 and 8)
  • Glucose postprandial response(weeks 4 and 8)
  • Insulin postprandial response(weeks 4 and 8)
  • Basal Total Cholesterol(weeks 0, 4 and 8)
  • HDL-Cholesterol(weeks 0, 4 and 8)
  • Triglycerides Levels(weeks 0, 4 and 8)
  • LDL-cholesterol(weeks 0, 4 and 8)
  • C-Reactive Protein(weeks 0, 4 and 8)
  • Homocystein(weeks 0, 4 and 8)
  • Dietary intake(during first period (week 0-4) and second period (week 4-8))
  • Satiety assessment(weeks 4 and 8)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo Martinez

Main investigator

Clinica Universidad de Navarra, Universidad de Navarra

研究点 (2)

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