NCT02068144已完成不适用
The Effect of Daily Dietary Supplementation With Cranberry Extract on Modulation of Cardiovascular Risk Factors in Obese, Insulin Resistant Human Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8
研究概览
简要总结
The purpose of this study is to determine the health benefits of cranberry extract in people who are at risk for diabetes and heart problems.
详细描述
This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects with pre-diabetes will be randomized to receive either placebo or Cranberry extract for a total of 8 weeks of treatment. Each subject will continue on the same dosage of cranberry extract or matching placebo for the entire duration of treatment. Comparisons for insulin sensitivity, endothelial function, and markers of inflmmation and oxidative stress will be made between the 2 groups pre and post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 20 years of age or older
- •Not being treated with diabetes medication. However, if you are taking Metformin for pre-diabetes and are willing to stop taking the medication 2 weeks before and during the study that is ok. We will request clearance from your prescribing physician prior to stopping metformin and enrolling in the study.
- •Have a blood sugar of 100-125 mg/dL (fasting) or 140-199 mg/dL after a 2 hour glucose tolerance test (determined by tests done at the screening visit)
- •Have a fasting insulin more than or equal to 5 µIU/ml (determined by tests done at the screening visit)
- •Have a Body Mass Index (BMI) ≥ 30 and ≤ 45.
排除标准
- •Have a prior history of type 2 diabetes
- •Are pregnant or breastfeeding.
- •Are a woman able to have children and are not using birth control (i.e. barrier method, intrauterine and cervical devices, birth control pills, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), or have had a tubal ligation or hysterectomy, or not at least 2 years past menopause.
- •All women able to have children will have a pregnancy test at the screening visit. If you become pregnant during the study, you will be dropped from the study.
- •Have type 1 diabetes.
- •Are taking steroids (except topical or inhaled steroids).
- •Other medications that may affect your blood sugar (i.e. certain blood pressure medications) are acceptable if the dose has not changed in the previous 6 months and the dose will not change during the study.
- •Have a history or evidence of stomach or intestinal problems, e.g. irritable bowel syndrome; inflammatory bowel disease; ulcerative colitis or Crohn's disease; diverticulosis or diverticulitis; narrowing of the intestines, partial or complete removal of the stomach or small bowel; autonomic neuropathy consisting of difficulty swallowing; delayed stomach emptying or diarrhea; chronic, severe constipation; stomach or colon ulcers, or GI bleeding.
- •Use laxatives or cathartics on a chronic basis.
- •Take medications known to damage the kidneys, such as certain antibiotics, methicillin, and cyclosporin.
- •Have any evidence of kidney disease.
- •Have significant heart problems and/or history (within the last 6 months) of significant heart problems.
- •Have evidence within the previous 6 months of liver disease such as hepatitis; jaundice; cirrhosis.
- •Have clinically significant lung, neurologic, blood-related, immune system-related, cancer-related or metabolic disease.
- •Have had a recurrence of cancer within the past five years, other than treated basal cell carcinoma.
- •Are planning surgery during the study period.
- •Have a history of substance abuse or alcoholism within the past 5 years, or significant psychiatric disorder that would interfere with your ability to complete the study.
- •Have donated blood during the month before entering the study or are planning to donate blood during the study.
- •Have participated in other studies using a research medication during the previous 3 months.
- •Are currently smoking or have smoked within the past 6 months.
- •No smoking will be allowed during the study.
- •Have had a fluctuation in body weight >5% in the previous 2 months.
- •Are taking prescription or over-the-counter medication for weight loss.
- •Are taking weight loss or herbal supplements.
- •Are taking prescription or over-the-counter anti-inflammatory medications (such as naproxen, aspirin, ibuprofen).
- •Are allergic to cranberries
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo 15.2oz beverage daily for 8 weeks
干预措施: Placebo (Other)
Cranberry Extract
Experimental
Cranberry Extract in a 15.2oz beverage daily for 8 weeks
干预措施: Cranberry Extract (Dietary Supplement)
结局指标
主要结局
Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8
时间窗: 8 weeks +/- 2 days
Insulin sensitivity is tested using a 120 mU/m2 hyperinsulinemic-euglycemic clamp at 100mg/dL glucose over 2 hours at weeks 0 and 8
次要结局
- Change from baseline in endothelial function at week 7(8 weeks +/- 2 days)
- Change in body weight from baseline to week 8(8 weeks +/- 2 days)
- Change from baseline in Indirect Calorimetry at week 8(8 weeks +/- 2 days)
- Change from screening to week 8 in lipid profile(10 weeks +/- 2 days)
- Change in malondialdehyde at baseline and week 8(8 weeks +/- 2 days)
- Change in advanced glycation end products at baseline and week 8(8 weeks +/- 2 days)
- Change in Adiponectin at baseline and week 8(8 weeks +/- 2 days)
- Change in nitric oxide level at baseline and week 8(8 weeks +/- 2 days)
- Change in Paraoxonase at baseline and week 8(8 weeks +/- 2 days)
- Change in TNFα at baseline and week 8(8 weeks +/- 2 days)
- Change from screening to week 7 in oral glucose tolerance test (OGTT)(8 weeks +/- 2 days)
- Change in endothelin 1 level at baseline and week 8(8 weeks +/- 2 days)
- Change in oxidized LDL level at baseline and week 8(8 weeks +/- 2 days)
- Change in LOX-1 (Lectin-like oxidized low density lipoprotein-1) at baseline and week 8(8 weeks +/- 2 days)
- Change in Apo A1 at baseline and week 8(8 weeks +/- 2 days)
- Change in C-reactive protein (CRP) at baseline and week 8(8 weeks +/- 2 days)
- Change in 8-isoprostanes at baseline and week 8(8 weeks +/- 2 days)
研究者
Daniel Hsia
Principal and Medical Investigator
Pennington Biomedical Research Center
研究点 (2)
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