Effect of Daily Consumption of a Fiber-enriched Croissant on Metabolic Status, Dietary Habits and Gut Microbiota in Healthy Subjects (CROMA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Variation of daily energy intakes
研究概览
简要总结
The aim of this study is to evaluate the effect of a daily consumption for 2 weeks of a sourdough croissant enriched with dietary fibers vs a control sourdough croissant with no fiber added on daily energy intakes, fasting metabolic parameters, inflammatory status, blood pressure, anthropometric measures, body composition, appetite sensations, gastrointestinal functionality and gut microbiota composition.
详细描述
Associations between human health, diet and gut microbiota composition and functionality have been widely highlighted by the scientific literature in this field. Evidence shows that population adopting a Western dietary model, with a reduced intake of dietary fiber, undergo an adaptation of the gut microbiota characterized by the loss of some bacterial species and a general reduction in microbial biodiversity. The national guidelines for a healthy diet suggest to include daily fruit, vegetables, whole grains and legumes (the main sources of fiber in the diet) in the habitual diet to reduce the risk of diseases and to improve health. However, the compliance with these nutritional recommendations is generally low among individuals. Therefore, the commercial availability of dietary fiber-enriched products could be advantageous.
Breakfast is an important meal that should provide at least 20% of the daily calories with an adequate supply of all nutrients. Having fiber-enriched foods for breakfast could bring numerous nutritional benefits and if they are made with sourdough may be even better. Indeed, sourdough leavened baked products provide compounds with potential prebiotic activity, reduce the glucose and insulin response, increase satiety and reduce gastro-intestinal disorders upon consumption.
The hypothesis is that the combination of sourdough and dietary fiber in baked products could further ameliorate glucose metabolism in consumers compared to sourdough products.
The aim of this study is to evaluate the effects of a daily consumption at breakfast for 2 weeks of a sourdough croissant enriched with dietary fibers from 10 different sources vs a sourdough croissant with no fiber added (control) on daily energy intakes, metabolic and inflammatory status, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, body composition, blood pressure, gut microbiota composition and gastrointestinal functionality in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects;
- •men and women;
- •age 18-50 years;
- •20 kg/m2 ≤ BMI ≤ 35 kg/m2;
- •habitual daily breakfast consumption (≥ 250kcal/day);
- •habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
- •intake of fruit/vegetables < 3 servings/day;
- •low level of physical activity;
- •signed written informed consent.
排除标准
- •food allergies and intolerances and celiac disease;
- •gastrointestinal diseases;
- •relevant diseases;
- •pregnant or breastfeeding;
- •previous abdominal surgery;
- •hypertriglyceridemia (Triglycerides > 200 mg/dL);
- •hypercholesterolemia (Total cholesterol > 200 mg/dL);
- •hyperglycaemia (glycaemia ≥ 110 mg/dL);
- •hypertension (arterial blood pressure ≥140/90 mm Hg);
- •weight loss ≥ 3 kg within 2 months before the study;
- •antibiotics treatment within 3 months before the study;
- •any medication (different from antibiotics) at the enrollment and within 2 months before the study;
- •habitual diet characterized by high fruit and vegetables intakes (>3 portion/die);
- •high level of physical activity;
- •alcohol consumption ≥ 3 alcohol units per day;
- •simultaneous participation in other trial.
结局指标
主要结局
Variation of daily energy intakes
时间窗: 2 weeks
Calculation of total daily energy intakes based on 7 days food records
次要结局
- Changes in body weight(2 weeks)
- Changes in body mass index(2 weeks)
- Variation of fullness feeling scores(2 weeks)
- Variation of serum Insulin hormone concentration(2 weeks)
- Variation of urinary excretion levels of urolithins(2 weeks)
- Changes in fasting plasma inflammatory markers(2 weeks)
- Changes in fasting blood glucose(2 weeks)
- Variation of serum dipeptidyl-dipeptidase-IV activity(2 weeks)
- Changes in stool weight(2 weeks)
- Changes in hip circumference(2 weeks)
- Changes in waist circumference(2 weeks)
- Changes in blood pressure(2 weeks)
- Variation of hunger feeling scores(2 weeks)
- Variation of satiety feeling scores(2 weeks)
- Changes in fasting plasma lipids(2 weeks)
- Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration(2 weeks)
- Variation of urinary excretion levels of polyphenols(2 weeks)
- Changes in stool consistency(2 weeks)
- Changes in stool frequency(2 weeks)
- Changes in gastrointestinal functionality(2 weeks)
- Changes in faecal microbiome(2 weeks)
- Changes in body composition(2 weeks)
研究者
Paola Vitaglione
Associate Professor
Federico II University