Improving Resilience With Whole Grain Wheat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in cardio-metabolic health parameters (composite)
研究概览
简要总结
This study investigates the health benefits of whole grain wheat on cardiovascular/ cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal challenge. This study also investigates the health benefits of whole grain wheat (WGW) on liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices in quantifying health effects in a nutritional intervention study.
详细描述
The study is a randomized controlled, double blind, parallel trial. A 4-week run-in period with refined wheat (RW) products will be included prior to the intervention for all subjects. Thereafter, two different treatments will be evaluated e.g. a 12-week intervention with whole grain wheat (WGW) products (98g of WGW per day) and a 12-week control intervention with RW products. Two experimental visits will be planned before and two experimental visits will be planned after the 12-week intervention period. In the first experimental visit the investigators will determine liver fat and abdominal fat distribution by magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI). In the second experimental visit the investigators will comprehensively phenotype the participants which will include the response to a mixed meal challenge test.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or postmenopausal females (target 50: 50 for both genders) For females: menstrual cycle absent for more than 1 year
- •Age 45-70yrs
- •BMI between 25 and 35 kg/m2
- •Signed informed consent
- •Normal food habit of bread and cereal consumption
排除标准
- •Not having a general practitioner
- •Having a history of medical or surgical events that may significantly affect the study outcome
- •Use of cholesterol lowering medication
- •Mental status that is incompatible with the proper conduct of the study
- •Aversion, intolerance to gluten, whole wheat or other items in the intervention products
- •Alcohol consumption of > 21 glasses a week
- •Abuse of drugs
- •Recent use of antibiotics (<1 month prior to day 01 of the study)
- •Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening
- •Reported slimming or medically prescribed diet
- •Reported vegan or macrobiotic life-style
- •Not willing to give up blood donation during the study
- •Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
- •Current participation in other research (with the exception of NQplus)
- •Contraindication for MRI
- •Having blood vessels that are too difficult for inserting a cannula
结局指标
主要结局
Change in cardio-metabolic health parameters (composite)
时间窗: Baseline and after 12 week intervention (at 0 and 12 weeks) , during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)
parameters include change in cholesterol, TAG, glucose, insulin, FMD (Fasting only), pulse wave analysis (Fasting and 120, 240min postprandial), blood pressure(Fasting and 120, 240min postprandial), blood cell activation (Fasting only) and plasma markers of cardio-vascular health
次要结局
- Change in liver-and adipose tissue health parameters (composite)(Baseline and after 12 week intervention (at 0 and 12 weeks), during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial))
- Change in health and mood questionaire outcomes(At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks))
- Change in blood markers of whole grain intake(before and after 12 week intervention (at 0 and 12 weeks))
- Change in do-it-yourself measure outcomes (composite)(At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks))