Health Effects and Consumer Aspects of Different Types of Bread
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
研究概览
简要总结
Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Production of bread has changed from the traditionally use of sourdough, to yeast (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production. Sourdough naturally contains bacteria, and through the fermentation process these bacteria release several components that are not found in modern bread using yeast. It has been shown that sourdough may have positive health effects, including on blood glucose regulation. The aim of the project is to investigate if intake of sourdough may give positive health effects compared to beard with yeast.
详细描述
The investigators aim to include approximately 20 participants in this randomized controlled double-blind cross-over study lasting for 5 weeks.
All participants will be given bread baked with yeast for a 2 weeks run-in period. The participants will then be randomly assigned to either 1 week intervention with bread baked with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1 week intervention period the participants starting with bread baked with yeast will be given sourdough and vice versa.
Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected before and after the intervention periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults who restrict their intake of bread due to stomach ache.
排除标准
- •Chronic metabolic diseases, such as diabetes type 1 or 2, cardiovascular diseases and cancer last 6 months
- •Gut diseases, including Chron's disease, ulcers colitis
- •Food allergies or intolerance
- •Pregnant and/or lactating
- •BMI <18,5 and >27 kg/m2
- •Planed weight reduction and/or ± 5% weight change last 3 months
- •Blood donor last 2 months and during the study period
- •Not willing to quit taking dietary supplements, including probiotics, cod liver oil etc., 4 weeks prior to study start and during the study
- •Use of antibiotics <3 months prior to study start and during the study
- •Alcohol intake >40 g/day
- •Hormone treatment (except contraceptives)
结局指标
主要结局
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
时间窗: 5 weeks
GSRS-IBS analysis after intervention with bread baked with yeast versus sourdough with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)
次要结局
- Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids(5 weeks)
- Bristol stool chart (BSC)(5 weeks)
- Iron, selenium and zinc in blood(5 weeks)
- Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)(5 weeks)