Bakery Products for Non-Coeliac Gluten Sensitive Consumers
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score)
研究概览
简要总结
The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. To make this bread, the investigators will use advanced enzyme technology and/or novel formulations to target the digestion or removal of wheat proteins, which might be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other those that are more useful for baking quality. The investigators will determine palatability and tolerance of this new product in a human cross-over, randomised, blind and placebo-controlled intervention study.
It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac disease (CD). Three breads will be produced and tested in this study against a suitable reference based on standard wheat flour and baking process
详细描述
Prior to the study each volunteer will undergo screening procedure (Health Screening Questionnaire) for compliance with the inclusion/exclusion criteria. The volunteers who meet those criteria will be invited to sign an informed consent. Following this the volunteers will be asked to complete:
- Gluten Sensitivity Questionnaire
- SF-36 Quality of Life Questionnaire
- Beacke Physical Activity Questionnaire
- DASS 21 Questionnaire
It is anticipated that NCGS volunteers are following a low gluten or gluten-free life style. Evaluation of their dietary compliance with gluten-free diet will be done through using numerical scores (Biagi at al.,2009) - a system based on strategies that the subjects use to avoid eating gluten.
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of overall abdominal symptoms, abdominal pain, bloating, wind, satisfaction with stool consistency, tiredness, and nausea.
Severity of fatigue will be evaluated by the Daily-Fatigue Impact Scale (D-FIS), a questionnaire containing 8 items that evaluates the impact of fatigue on cognition, physical functioning, and daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, aged 18-70, who believe they experience non-coeliac gluten sensitivity
排除标准
- •Medical exclusion criteria
- •Coeliac Disease
- •Wheat allergy
- •Dermatitis Herpetiformis
- •Gastrointestinal disorders: Small Intestinal Bowel Overgrowth (SIBO), Crohn's disease , Ulcerative Colitis, Inflammatory Bowel Disease (IBD)
- •History of gastrointestinal surgery/procedure over the last 3 years
- •Kidney disease
- •Hepatic disease
- •Active cancer
- •Severe cardiovascular disease
- •Addiction to any substances
- •Breastfeeding/ Pregnancy
- •Volunteers with poorly controlled psychiatric disease or those unable to give written informed consent will also be excluded.
- •Medication exclusion criteria
- •Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives
- •Digestive enzymes
研究组 & 干预措施
Group 3
Begins with Bread with reduced ATIs content
干预措施: Bread with reduced ATIs content (Other)
Group 1
Begins with Normal gluten containing bread
干预措施: Normal gluten containing bread (Other)
Group 2
Begins with Bread with reduced gliadins content
干预措施: Bread with reduced gliadins content (Other)
Group 4
Begins with Bread with reduced overall protein content
干预措施: Bread with reduced overall protein content (Other)
结局指标
主要结局
Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score)
时间窗: These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of abdominal pain, bloating, wind and nausea.
次要结局
- Change in the presence and severity of daily fatigue (Daily-Fatigue Impact Scale (D-FIS)(Fatigue will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9))