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
- 否
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
Dra Monica Bullo
Principal Investigators
Institut Investigacio Sanitaria Pere Virgili
研究点 (2)
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