NCT02041975已完成不适用
Investigating the Effects of Prebiotic-based Snacks on Perceived Feelings of 'Satisfaction' and on the Balance of Bacteria in the Human Gut (NutriSAT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Differences in perceived appetite (assessed using visual analogue scales)
研究概览
简要总结
To determine the effects of prebiotic 'snacks' on gut health and satisfaction between meals
详细描述
The role of the bacteria that reside in the human gut play in human health and disease is of increasing importance. Evidence gathered over recent decades' shows that certain bacteria can improve resistance to gut infections, reduce cholesterol levels, synthesise vitamins and improve the immune response. The potential to modulate the relative balance of these so-called 'beneficial' bacteria has been demonstrated through the use of certain fibre sources termed prebiotics. In addition there is interest to understand how snacks containing these fibre sources may affect levels of 'satisfaction' between meals. The current study will address these issues and lead to a greater understanding of the role that prebiotics may play in gut health and overall metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 22 and 55 years
- •Healthy (no medical conditions in the last 12 months)
- •BMI between 22.0 and 27.9 kg/m2
- •Non-smokers
- •Not a vegetarian or vegan
- •No antibiotics in the last 6 months
- •Not donated more than 350 ml blood in 4 months prior to or following study
排除标准
- •Had surgery or suffered a medical condition affecting the circulatory, nervous or digestive systems in the previous 12 months
- •Had suffered a myocardial infarction or stroke in the previous 12 months
- •Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting
- •Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)
- •Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease [including proton pump inhibitors (e.g. Omeprazole, Esomeprazole, Lansoprazole or Pantoprazole), non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen or diclofenac) or anti-anxiety medication (e.g. benzodiazepine)]
- •Use of antibiotics within the previous 6 months
- •Any dietary restrictions or on a weight reducing diet
- •Irregular eating patterns and those not consuming breakfast
- •Any food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)
- •Use of medication which affects food intake or behaviour (e.g. anti-depressants)
- •Use of medication likely to affect taste, smell or appetite
- •Use of cholesterol lowering drugs/functional foods (e.g. Flora pro-activ)
- •Dietary fibre consumption > 20 g/d
- •Those that dislike the study foods and beverages
- •Three Factor Eating Questionnaire (TFEQ) Factor 1 score >13
- •Use of any vitamin supplements or fish oil capsules
- •A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men)
- •Athletes in training (> 8 h exercise/week)
- •Amount of sleep each night (<5 hours/night)
- •Females who are breast-feeding, may be pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
- •Involvement in a study involving an experimental drug/medication within 4 weeks prior to entry to the study
- •History of chronic constipation or diarrhoea, or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
- •Intake of other supplementary prebiotics (such as oligosaccharides, e.g. FOS, GOS) or probiotics, drugs active on gastrointestinal motility such as antidiarrheals (e.g. medicines containing loperamide, bismuth subsalicyte or atropine/diphenoxylate), medication for abdominal pain and intestinal discomfort (e.g. duspatalin) or laxatives of any class (medications containing e.g. polyethylene glycol 3350, bisacodyl, methylcellulose or lactulose) during or within the four weeks prior to the start of the study
- •Aged below 22 or over 55 years
- •Have a Body Mass Index (BMI) of less than 22 or more than 27.9 kg/m2 [for volunteers of Asian origin; BMI of less than 21, or between to 23 to 25, or above 27 kg/m2].
- •Blood pressure > 160/90 mmHg
- •Vegan or vegetarian
- •Donated > 350 ml of blood within the 4 months prior to the study or plan on donating > 350 ml of blood within the 4 months following the study.
研究组 & 干预措施
Prebiotic
Experimental
Nutriose FB06 14g/day
干预措施: Nutriose FB06 (Dietary Supplement)
Placebo
Placebo Comparator
Maltodextrin
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Differences in perceived appetite (assessed using visual analogue scales)
时间窗: Within 18 months
次要结局
- Alterations to the relative balance of bacterial groups in faeces (assessed using flow cytometry)(Within 18 months)
研究者
研究点 (1)
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