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临床试验/NCT01441921
NCT01441921已完成不适用

Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus

Institut Investigacio Sanitaria Pere Virgili2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm

研究概览

简要总结

Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.

详细描述

In free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on:

  • Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation end products and soluble receptor of advanced glycation-end products.
  • Peripheral haemostatic parameters.
  • Plasma inflammatory markers.
  • Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in peripheral leukocytes.
  • Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes.
  • Platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane B2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • BMI less than 35 kg/m
  • Fasting plasma glucose levels between 100 and 125 mg/dl or
  • Oral glucose tolerance test of 140 to 199 mg/dl.

排除标准

  • Diabetes mellitus.
  • Alcohol, tobacco, or drug abuse.
  • Significant liver, kidney, thyroid, or other endocrine diseases.
  • Frequent consumption of nuts or known history of allergy to them.
  • Use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin E or other antioxidant supplements.
  • Bad dentures, implying difficulty to chew pistachios.
  • Being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study.
  • Following vegetarian or weight loss diets.
  • Other medical or social conditions that difficult the compliance to the intervention.

研究组 & 干预措施

Control diet

Active Comparator

Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)

干预措施: control diet (Other)

Pistachio diet

Experimental

Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)

干预措施: Pistachios (Dietary Supplement)

结局指标

主要结局

Changes from baseline in circulating levels of glucose and insulin according to the intervention arm

时间窗: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

Measurement of circulating glucose and insulin levels and cellular glucose uptake

次要结局

  • Changes from baseline in HL and LDL size according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes in advanced glycation end products according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in gene expression in the peripheral cells according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in platelet function according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in haemostatic parameters according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in cellular glucose uptake according to the intervention arm(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
  • Changes from baseline in telomeric length of leukocytes (LTL)(Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first intervention arm. Measurements will be not analysed after the second period due to expected carry-over effect.)

研究者

发起方
Institut Investigacio Sanitaria Pere Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dra Monica Bullo

Principal Investigators

Institut Investigacio Sanitaria Pere Virgili

研究点 (2)

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