Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status in Overweight and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in fasting plasma glucose
研究概览
简要总结
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
详细描述
Growing evidence highlights the role of the individual diet and gut microbiome in modulating human metabolism, inflammatory status and cardiovascular risk.
This scenario supports nutritional approaches targeted to modify gut microbiota composition to trigger health benefits and the interest to develop novel functional foods enriched with probiotics. Most of commercial probiotic foods are in the category of dairy products and contain Lactobacillus strains. Besides that, Bacillus spp. along with the ability to form spores show probiotic attributes by exhibiting pathogen exclusion and antioxidant, antimicrobial and immune-modulatory abilities. Furthermore, they possess a stronger viability and stability to withstand high temperature processes, such as baking and boiling, than other probiotic bacteria thus representing an ideal choice for the development of functional cereal-based products.
In particular, Bacillus clausii UBBC07 exhibits probiotic properties by alleviating the severity and symptoms of acute diarrhoea in adults and children and show a high stability over a wide range of temperatures with potential applications in a variety of formulations and foods. The health benefits of B. clausii UBBC07 in overweight and obese subjects is unexplored.
This study aims to investigate the effects of consumption for 4 weeks of a probiotic durum wheat pasta enriched with spores of B. clausii UBBC07 vs a conventional durum wheat pasta (control) on metabolic and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects;
- •men and women;
- •age 18-65 years;
- •25 kg/m2 ≤ BMI ≤ 35 kg/m2;
- •habitual daily pasta consumption (≥ 1 portion/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 (< 500 metabolic equivalent min/week);
- •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.
研究组 & 干预措施
Probiotic Pasta Group
Subjects in the Probiotic Pasta group will consume 80 g per day of a probiotic pasta for 4 weeks
干预措施: Probiotic Pasta (Other)
Control Pasta Group
Control Pasta Subjects in the Control Pasta group will consume 80 g per day of conventional pasta for 4 weeks.
干预措施: Control Pasta (Other)
结局指标
主要结局
Changes in fasting plasma glucose
时间窗: 1 months
Measure of plasma glucose concentrations (mg/dL)
Changes in fasting inflammatory blood markers
时间窗: 1 months
Measure of plasma C-reactive protein (mmol/L)
Changes in fasting plasma lipids
时间窗: 1 months
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
次要结局
- Changes in body weight(1 month)
- Changes in small intestine permeability(1 month)
- Changes in colonic permeability(1 month)
- Variation of plasma glucagon like peptide-1 concentration(1 month)
- Variation of plasma Glucagon hormone concentration(1 month)
- Variation of plasma Ghrelin hormone concentration(1 month)
- Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration(1 month)
- Variation of serum dipeptidyl-dipeptidase-IV activity(1 month)
- Changes in stool weight(1 month)
- Changes in stool frequency(1 month)
- Changes in faecal microbiome(1 month)
- Changes in stool consistency(1 month)
- Changes in gastrointestinal functionality(1 month)
- Variation of plasma gastric inhibitory polypeptide hormone concentration(1 month)
- Variation of plasma Insulin hormone concentration(1 month)
- Changes in body mass index(1 month)
- Changes in waist circumference(1 month)
- Changes in hip circumference(1 month)
- Changes in blood pressure(1 month)
- Changes in body composition(1 month)
- Variation of daily energy intakes(1 month)
- Variation of hunger sensation scores(1 month)
- Variation of fullness sensation scores(1 month)
- Variation of satiety sensation scores(1 month)
- Variation of wellbeing status(1 month)
研究者
Paola Vitaglione
Associate Professor
Federico II University