Extrait

Background and study aims Many people regularly experience bowel symptoms such as straining or a feeling of incomplete evacuation (not passing all the stool). Research suggests that a healthy stool weight and gut transit time (the time it takes for food to pass through your gut) can reduce the risk of these symptoms and some bowel disorders, such as colorectal cancer. Changes in diet can influence bowel health, for example fibre may help to increase stool weight and maintain a regular bowel habit, therefore the use of dietary intervention has much promise for helping to prevent bowel disorders. Fibre and fluid may help to maintain a regular bowel habit and increase stool weight, but it is not clear which fibre foods or natural fluids are most effective. This study aims to investigate the effect of specific natural foods and fluids on bowel habit, stool weight, gut transit time and other markers of bowel health. Who can participate? To take part in this study you need to be aged between 18 and 65 and typically have a low fibre intake and a bowel movement between 3 and 6 times per week. If you have a chronic disease, or take medications, supplements, or food products likely to affect gut motility you will not be able to take part. If you are pregnant or lactating or have undergone procedures involving ionising radiation to the abdomen or pelvic region in the last 12 months you will not be able to take part. What does the study involve? In this study we will ask you to add a specific natural food or fluid to your normal diet for 4 weeks. However, your total involvement in the study will be for 10 weeks. This is so we can gather information before and after we ask you to add the food or fluid into your diet. Throughout the study you should continue to eat your normal diet and maintain your usual level of physical activity. We will ask you to attend four appointments at King's College London (KCL). At these appointments we will gather information using questionnaires and face-to-face interviewing. We will also measure your height, weight and percentage body fat. When you visit us at KCL we will ask you to complete questionnaires on your physical activity level, your appetite and the acceptability of the intervention. We will ask you to attend two to four appointments at Queen Mary, University of London for X-rays to be taken so that we can assess your gut transit time. Before each X-ray appointment we will ask you to take two capsules of 'markers' at a specific time of day for 3 days. There is no known risk to health of taking these capsules, and they are commonly used in research studies to assess gut function. We will ask you to carry out two 7-day stool collections. This would involve collecting all the stools you pass for a period of 7 days. We will give you full instructions and equipment to help with this. We will also ask you to complete various diaries during the study: A 7-day stool and symptom diary, in which you record how often you open your bowels and the frequency with which you experience any bowel symptoms such as wind, pain, or bloating. A 7-day food and drink diary, in which you record everything you eat and drink. A compliance diary, in which you record when you take the food or fluid we have asked you to add to your normal diet. We will ask if you would like to give an optional blood sample at 2 points during the study. The sample will be approximately 10 ml (1 dessertspoon) of blood. We will use this sample to investigate how your body absorbs the food or fluid we have asked you to add to your diet. What are the possible benefits and risks of participating? If you participate in this trial you may experience an improvement in bowel function. Possible side effects include mild gastrointestinal symptoms such as bloating and flatulence, however, the prune dose selected for this trial has been reported to be well tolerated in previous studies. If you choose to provide a blood sample this may be associated with discomfort and may leave a temporary bruise. The risks associated with the X-rays are considered to be small. However, if you are pregnant you should not take part as there is a small risk that X-rays can harm an unborn baby. Where is the study run from? The study is led by King's College London. The gastrointestinal transit time measurements will be undertaken at Queen Mary University London. When is the study starting and how long is it expected to run for? Participants will be recruited to the trial from approximately January 2012 to October 2012. Who is funding the study? California Dried Plum Board, USA Who is the main contact? Dr Kevin Whelan [email protected]

Critère d'inclusion

• Gastrointestinal Health

Liens

• isrctn
• ictrp