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临床试验/NCT01010841
NCT01010841已完成不适用

Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

MetaProteomics LLC2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2008年8月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
TG-to-HDL ratio
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome.

详细描述

As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that specific phytochemical supplementation for 12 weeks (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins) increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD in subjects with metabolic syndrome and elevated LDL cholesterol. In this study, we propose to conduct a multi-center randomized trial to confirm our previous findings.

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
None

入排标准

年龄范围
20 Years 至 75 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •BMI ≥25 and <45
  • •LDL >100 mg/dl
  • •TG ≥150 and <400 mg/dl
  • •meet 2 or more of the following 4 criteria:
  • •HDL <50 mg/dl
  • •blood pressure ≥130/85 mmHg (or diagnosed hypertension on medication)
  • •fasting glucose ≥100 mg/dl and <150 mg/dl
  • •waist circumference >35 inches

排除标准

  • •Medical History and Concurrent Diseases
  • •Over the preceding 4 weeks, initiation or cessation of regular exercise
  • •Over the preceding 4 weeks, involvement in a significant diet or weight loss program such as Atkin's diet program, a very low calorie liquid program (such as Optifast, Medifast, and HMR), or any diet that has led to a weight loss of 10% of body weight over a period of 6 weeks
  • •Use of blood sugar lowering medications including thiazolidinedione class of oral medications including Avandia (rosiglitazone), Avandamet (metformin/rosiglitazone), Actos (pioglitazone), metformin (Glucophage, Fortamet, Riomet) or insulin over the preceding 12 weeks
  • •Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
  • •Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
  • •Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
  • •Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
  • •Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
  • •Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
  • •Allergy to one or more of the ingredients in the investigational products
  • •Poorly controlled hypertension (blood pressure above 155/95)
  • •History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
  • •History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
  • •History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
  • •History of autoimmune diseases such as inflammatory bowel disease (Crohn's disease, and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma and thyroiditis
  • •History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
  • •History of alcoholism or drug addiction in the preceding 5 years
  • •History of serious mental illness
  • •History of attempted suicide in past 10 years
  • •Untreated endocrine, neurological, or infectious disorder
  • •Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
  • •Current cancer or a history of cancer (except skin cancer)
  • •Pregnancy or lactation
  • •If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)
  • •Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI).
  • •Physical and Laboratory Test Findings
  • •TG ≥ 400 mg/dl
  • •abnormal blood count (Hct < 30 or > 47%, WBC < 3,000 or > 12,000, platelets <140 or > 500)
  • •abnormal kidney function test(s) (BUN > 30 mg/dL or creatinine > 1.5 mg/dL) or liver function test(s) (bilirubin total > 2.0 mg/dL, ALT > 75 IU/L, AST > 75 IU/L; Alk Phos > 130 IU)
  • •fasting glucose >150 mg/dL, serum calcium (>10.5 mg/dL), positive pregnancy test (ß-hCG in blood)

结局指标

主要结局

TG-to-HDL ratio

时间窗: Baseline, 8 weeks, 12 weeks

次要结局

  • Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)(Baseline, 8 weeks, 12 weeks)
  • CVD risk factors (cholesterol, LDL, chol/HDL, apoAI, apoB, apoAII, apoCII, apoCIII, apoE, homocysteine, RBC fatty acids, Framingham risk score)(Baseline, 8 weeks, 12 weeks)
  • Components of metabolic syndrome (TG, HDL, resolution of MetS)(Baseline, 8 weeks, 12 weeks)
  • Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)(Baseline, 8 weeks, 12 weeks)
  • Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)(Baseline, 8 weeks, 12 weeks)
  • Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)(baseline, then every 2 weeks)

研究者

发起方
MetaProteomics LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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