The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4
研究概览
简要总结
Wheat germ is a by-product of the wheat-milling industry with high nutritional value and therefore could be used as a raw source for the preparation of food products such as bread, cookies, muffins, etc.
The aim of this study is to assess the effects of ingesting wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.
详细描述
This is a crossover, double blinded, placebo controlled randomized trial. The study will compare the effect of consumption of wheat breads with or without wheat germ on healthy individuals, during 2 intake periods of 4 weeks each and 5 weeks washout before crossover.
The study will focus on the effects of wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men or women
- •Age 18 - 60 years
- •Healthy volunteers free of chronic diseases with relevant effect on the gastrointestinal system or on visceral motility
- •Without a diagnosis of any digestive disease including functional bowel disorders such as IBS
- •Non-diabetic, no gastric bypass surgery
- •Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L)
- •Non-smoker
- •Willing and able to provide written informed consent
排除标准
- •Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
- •Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
- •Subjects with stool frequency of ≤ 1 stool every 7 days
- •Subjects not willing to avoid pre- and probiotics for the duration of the study
- •Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
- •Current use of medication for lowering blood cholesterol or glucose
- •Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibres)
- •Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study
- •Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
- •Known food intolerance or allergy
- •Subject involved in any clinical or food study within the preceding month
结局指标
主要结局
Changes in fasting serum C-reactive protein from baseline to visit 2, 3 and 4
时间窗: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in fasting serum total cholesterol from baseline to visit 2, 3 and 4
时间窗: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)
Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2, 3 and 4
时间窗: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in mean Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to weeks 2, 4, 7, 9, 11 and 13
时间窗: at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover)
A validated PAC-SYM questionnaire will be used. PAC-SYM is a 12-item, self-administered questionnaire used to measure severity of symptoms over the past 2 weeks in patients with constipation. The PAC-SYM questionnaire has been demonstrated and documented to have internal consistency, reproducibility, validity, sensitivity, and responsiveness. PAC-SYM items are rated on a 5-point scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe) and grouped into three subscales related to abdominal symptoms (bloating, discomfort, pain, and cramps), stool symptoms (incomplete bowel movement, false alarm, straining, too hard, and too small), and rectal symptoms (painful bowel movement, burning, and bleeding or tearing). The total score and subscale scores are computed by taking the mean of item responses (score range 0-4). A reduction in score reflects an improvement in symptoms. Cultural adaptation and linguistic validation of the PAC-SYM for Portugal was performed by Mapi Research.
Changes in fasting serum triglycerides from baseline to visit 2, 3 and 4
时间窗: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and visit 4 (after 4-week intake period after crossover)
Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2, 3 and 4
时间窗: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
Changes in capillary blood glucose from baseline to visit 2 and 4
时间窗: 0, 30, 60 and 120 minutes post-meal: at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover)
次要结局
- Changes in mean Perceived Stress Scale (PSS) score from baseline to weeks 4, 9 and 13(at the end of week 0 (after 2-week run-in period), at the end of week 4 (after 4-week intake period), at the end of week 9 (after 5-week washout period), and at the end of week 13 (after 4-week intake period after crossover))
- Changes in intestinal microbiota from baseline to visit 2, 3 and 4(at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period), and visit 4 (after 4-week intake period after crossover))
- Changes in stool frequency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13(at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9))
- Changes in mean daily abdominal discomfort score from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13(daily during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period (weeks 5, 6, 7, 8 and 9))
- Changes in stool consistency from baseline to weeks 1, 2, 3, 4, 10, 11, 12 and 13(at days with stool during run-in period (weeks -1 and 0), intake period (weeks 1, 2, 3, 4, 10, 11, 12 and 13), and washout period ( weeks 5, 6, 7, 8 and 9))
- Changes in fasting plasma insulin from baseline to visit 2 and 4(at visit 1 (after 2-week run-in period), visit 2 (after 4-week intake period), visit 3 (after 5-week washout period) and at visit 4 (after 4-week intake period after crossover))
- Changes in mean Patient Assessment of Constipation Quality of Life (PAC-QOL) score from baseline to weeks 2, 4, 7, 9, 11 and 13(at the end of week 0 (after 2-week run-in period), at the end of weeks 2 and 4 (during 4-week intake period), at the end of weeks 7 and 9 (during 5-week washout period), at the end of weeks 11 and 13 (during 4-week intake period after crossover))