NCT01260272已完成不适用
A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Cardiovascular Risk Factors In Generally Healthy Subjects
Louisville Metabolic and Atherosclerosis Research Center2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年12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
- 49
- 试验地点
- 2
- 主要终点
- Percent Change in Postprandial Glucose Levels
研究概览
简要总结
This trial compared the effects of raisin intake on cardiovascular risk factors compared to common, commercially available, alternative snacks. These cardiovascular risk factors include glucose, blood pressure, lipid levels, body weight, and waist circumference.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are generally healthy men and women older than 18 years of age.
- •Are willing and able to undergo the informed consent process.
- •Have body mass index (BMI) from 25.0 to 34.9 kg/m².
- •Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
- •Have blood pressure > 120 mmHg systolic or > 80 mmHg diastolic.
- •Are willing to notify the research staff of any change in their medical health & concomitant medications/supplements during the course of the clinical trial.
排除标准
- •Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
- •History of > one "food allergy."
- •Weight loss of > 5 pounds in last 2 months
- •Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
- •Blood pressure >160 mmHg systolic or >100 mmHg diastolic.
- •Fasting serum lipoprotein values of: LDL-cholesterol, >160 mg/dl or triglycerides, >500 mg/dl.
- •Creatinine level > 1.5 times the upper range of normal.
- •Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)
- •Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
- •Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.
- •Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.
- •Is pregnant, breastfeeding or plans to become pregnant during the next three months.
- •Is an employee or immediate family member of the research staff.
- •Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
- •Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.
- •Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
- •Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.
- •History of severe or uncontrolled depression based on Principal Investigator.
- •Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
- •Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.
- •History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.
- •History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.
- •History of organ transplant.
- •History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
- •Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
- •Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.
- •Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
- •Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
- •Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.
- •Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.
- •Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.
- •Reasonable life-expectancy of less than 2 years.
- •Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.
结局指标
主要结局
Percent Change in Postprandial Glucose Levels
时间窗: 12 weeks
Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12
Percent Change in Fasting Glucose Levels
时间窗: 12 weeks
Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12
Percent Change in Body Weight
时间窗: 12 weeks
Raisin versus snacks: percent change in body weight from baseline to week 12
次要结局
- Change in Systolic Blood Pressure(12 weeks)
- Change in Diastolic Blood Pressure(12 weeks)
- Change in Hemoglobin A1c(12 weeks)
- Change in Waist Circumference(12 weeks)
- Change in High Density Lipoprotein Cholesterol Levels(12 weeks)
研究者
Harold E. Bays
Principal Investigator
Louisville Metabolic and Atherosclerosis Research Center
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes MellitusDiabetes MellitusNCT01677936Louisville Metabolic and Atherosclerosis Research Center51
已完成
1 期
Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585Pulmonary Arterial HypertensionNCT02746237Karos Pharmaceuticals120
撤回
4 期
Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes PatientsType 2 DiabetesNCT00399204Post Graduate Institute of Medical Education and Research, Chandigarh
终止
3 期
Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular DiseaseType 2 DiabetesCardiovascular DiseaseNCT01609582Takeda3,207
已完成
3 期
A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)Rheumatoid Arthritis,OsteoarthritisNCT00250445Organon and Co23,498