Effect of Strawberry on Oxidative Stress- and Inflammatory-mediated Insulin Resistance (IR) in Humans: Combating a Major Risk Factor for Diabetes and Cardiovascular Disease Through Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Postprandial Insulin Levels for 6 Hours
研究概览
简要总结
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high fat/carbohydrate meal.
详细描述
The main study is a single-center, randomized, cross-over, 4-arm, dose-response, single- blinded, 6-hour postprandial study to evaluate the ability of strawberry powder to block meal-induced oxidative stress and inflammation and concomitantly improve postprandial insulin sensitivity and glucose handling.
A planned sample size of 45 will be recruited into the study. Thirty subjects for the main study and 15 subjects for the complement study. Subjects can participate in both studies and if subjects participate in both studies, there will be a time gap between the main study and the complement study due to the volume of blood permitted to collect within 56 days.
The complement study will be a 2-arm placebo controlled study following the exact same protocol as the main study, but using only one strawberry dose (Dose 3 as in the main study) and comparing the effects relative to a placebo that does not control for fiber.
The main study will take 5- 6 weeks per subject to complete and the complement study will take 1-2 weeks per subject to complete, depending on subject's schedule.
The procedures conducted at the screening visit include blood sampling by finger prick for a fasting blood sugar test and anthropometric measurements (height, weight, and waist circumference), vital sign measurements (blood pressure and heart rate) and completion of a series of questionnaires relating to volunteers' general health and eating habits. Volunteers may be asked to complete an oral glucose/sugar tolerance test (OGTT) at screening. Volunteers will be exempt from the OGTT procedure if other qualifying conditions are present. Briefly, subjects undergoing OGTT will be asked to drink a glucose drink (similar in taste to kool-aid) in the morning after a 10 hour fast. Blood glucose finger pricks will then be done at 1 hour and 2 hours for determination of glucose tolerance. If the OGTT is necessary, additional compensation will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Eligible volunteers must meet ONE or MORE of the criteria (numbers 1-4) associated with insulin resistance along with all of the other criteria listed (numbers 5-9):
- •Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
- •Elevated fasting glucose (≥110 mg/dL and <126 mg/dL)
- •Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL)
- •Insulin resistance defined by the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose [in millimoles per liter] × insulin [in microunits per milliliter]/22.5) values of at least 2.
- •Waist circumference >102 cm (men) and > 88 cm (women) for screening visit invitation because many epidemiology studies have been shown that waist circumferences may be related to insulin resistance.
- •Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
- •18 years of age and older
- •No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
排除标准
- •Pregnant and/or lactating
- •Allergy or intolerance to strawberries and dairy products.
- •Current regular consumption of strawberries is > 2 servings per day.
- •Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care.
- •Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints.
- •Subjects with unusual dietary habits (e.g. pica).
- •Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period).
- •Excessive exercisers or trained athletes.
- •Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases.
- •Addicted to drugs and/or alcohol.
- •Medically documented psychiatric or neurological disturbances.
- •Smoker (past smoker may be allowed if cessation is > 2 years)
结局指标
主要结局
Postprandial Insulin Levels for 6 Hours
时间窗: 6 hour postprandial study over 4 periods
Strawberry dose-response effect on Postprandial glycemic control in insulin resistant individuals.plasma insulin concentration is measured over 6 hours by Randox clinical analyzer, analyzed with SAS mixed model.
次要结局
- Strawberry Dose-response Effect on Postprandial Oxidative Stress (Ox-LDL) in Insulin-resistant Men and Women in an Acute Postprandial Paradigm(6 hours postprandial study over 4 periods(treatments))