Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes to glycemic control
研究概览
简要总结
Bread is the most common grain product in the world, with consumption surpassing 3 billion individuals per year. Sourdough whole-grain bread is considered a healthy alternative to white, refined-wheat bread.
This cross-over study will test the effect of consumption of sourdough bread compared to white bread following a short dietary intervention period (one week) on multiple clinical parameters and gut microbiota.
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
- None
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
- •Able to provide and signed informed consent form
- •Over 18 years
- •Not in active military service
- •Ability to technically operate a glucometer
排除标准
- •Prediagnosed type I / type II diabetes mellitus
- •Pregnancy
- •Usage of antibiotics within three months prior to participation
- •Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
- •Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
研究组 & 干预措施
Sourdough bread, white bread
Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week
干预措施: Consumption of sourdough bread (Other)
Sourdough bread, white bread
Consumption of sourdough bread for one week, 2 week washout, consumption of white bread for one week
干预措施: Consumption of white bread (Other)
White bread, sourdough bread
Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week
干预措施: Consumption of sourdough bread (Other)
White bread, sourdough bread
Consumption of white bread for one week, 2 week washout, consumption of sourdough bread for one week
干预措施: Consumption of white bread (Other)
结局指标
主要结局
Changes to glycemic control
时间窗: One week
Measured as response to an Oral Glucose Tolerance Test (OGTT; mg/dl\*h).
次要结局
- Changes to Magnesium levels (mg/dl)(One week)
- Changes to Thyroid Stimulating Hormone (TSH)(One week D)
- Changes to Iron levels (mg/dl)(One week)
- Changes to Lactate Dehydrogenase (LDH) levels(One week)
- Changes to LDL cholesterol levels (mg/dl)(One week)
- Changes to triglycerides levels (mg/dl)(One week)
- Changes to Creatinine levels (mg/dl)(One week)
- Changes to C-Reactive Protein (CRP) levels (mg/l)(One week)
- Changes to weight (Kg.)(One week)
- Changes to blood pressure (mmHg)(One week)
- Changes to Alanine Transaminase (ALT) levels (IU/l)(One week)
- Changes to Aspartate Transaminase (AST) levels (IU/I)(One week)
- Changes to Gamma-Glutamyl Transpeptidase (GGT) levels (IU/l)(One week)
- Changes to Urea levels (mg/dl)(One week)
- Changes to total cholesterol levels (mg/dl)(One week)
- Changes to HDL cholesterol levels (mg/dl)(One week)
- Changes to Basal Metabolic Rate (BMR; J)(One week)
- Changes to Calcium levels (mg/dl)(One week)