Acute Pharmacokinetics of Fig Polyphenols and Postprandial Glucose-Insulin Responses in Pre-diabetic Adults.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 5
- 试验地点
- 1
研究概览
简要总结
The study purpose is to understand how the body absorbs and metabolizes nutrient-like components in dried figs called polyphenols over 24 hours. The study is also done to know if polyphenols will help a hormone called insulin work better in the body, so to look further into the possibility of figs being a functional food for the pre-diabetic population.
详细描述
Recruited subjects must meet all eligibility criteria, sign and date a written Institutional Review Board (IRB)-approved Informed Consent Form.
The trial will test 2 dietary conditions which will be either the equivalent of one serving of dried California Mission Figs (40 g, ~120 kcal) or a calorie-matched control meal.
Pre-Screening: To learn more about the study and to pre-qualify, potential subjects can call the CNRC or visit the website posted on recruitment flyers or from other recruitment materials. If they call the CNRC, a staff member will provide a brief background on the study and ask a series of questions from a pre-screening questionnaire to see if they may be eligible to participate. The same questionnaire is available on the website and can be filled out by potential subjects online. The pre-screening questionnaire includes self-reported information about health status and lifestyle factors that can be used to determine if someone is not eligible for the study.
Information Session and Screening Session: Information Session and Screening Visit may occur simultaneously, or Information Session may occur prior to Screening Visit. Prior to the Screening Visit, potential subjects will be asked to arrive at the CNRC after an overnight-fast (stop eating after 10 pm) and be well-hydrated. Subjects should aim for drinking at least 8-10 cups of water the 24 h prior to the Screening Visit.
Information Session: At the CNRC, pre-screened subjects will participate in an Information Session where they will be informed of all study procedures and study schedules. If willing to adhere to all study procedures and schedules, they will be asked to read, ask questions, sign and date the Institutional Review Board (IRB) approved Informed Consent Form (ICF) before any laboratory or study screening procedures begin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be between 30-50 years old.
- •Have a BMI of 25-35 kg/m².
- •Have fasting blood glucose between 100-125 mg/dL or Glycated hemoglobin (HbA1c) between 5.7-6.4%.
- •Be non-smokers for at least 12 months.
- •Be generally healthy, with no major organ-related diseases.
- •Not take medications or supplements that could interfere with the study.
- •Be able to follow study procedures, including dietary restrictions and scheduled visits
排除标准
- •Vegetarian
- •Taking over the counter supplements (e.g. fiber supplements, probiotics and/or prebiotics, antioxidants, anti-inflammation) and/or taking prescription medications that may interfere with study procedures or endpoints (e.g. Gastrointestinal medications, antibiotics) within the last 30 days
- •Have cancer other than non-melanoma skin cancer in previous 5 years
- •Taking unstable dose of hormonal contraceptive and/or stable dose less than 6 months
- •Planning to become pregnant
- •Pregnant and/or breast-feeding
- •Excessive exercisers or trained athletes
- •Excessive coffee/tea drinker
- •Donated blood within last 3 months
- •Have allergies/intolerances to foods consumed in the study
- •Regular consumption of dried fruits exceeds > 2 servings per day
- •Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 lbs in 3 months)
- •Addicted to drugs or alcohol or have significant psychiatric or neurological disturbances
- •Past smokers may be allowed in the study if stopped >2 years
研究组 & 干预措施
Fig Breakfast
Standardized breakfast with 40g of figs
干预措施: Fig (Other)
Control breakfast
Standardized breakfast with calorie matched control ingredients
干预措施: Control (Other)
研究者
Indika Edirisinghe
Principal Investigator
Clinical Nutrition Research Center, Illinois Institute of Technology
