Healthy Effects of an Innovative Probiotic Pasta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Variation of fecal microbiota composition
研究概览
简要总结
The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.
详细描述
Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.
In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:
- blood inflammation markers;
- blood lipid and carbohydrate profile;
- blood and urine markers of cardiovascular risk;
- feces profile of microbiota and detection of markers for the healthiness of the gut.
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight / Obesity
- •Lower consumers of fruit and vegetables
排除标准
- •Antibiotic treatment within 3 months prior the pasta feeding
- •Chronic diseases
- •Surgeries
- •Consumer of whole grain products
- •Pregnant or lactating
研究组 & 干预措施
Control pasta
Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
干预措施: whole grain pasta (Dietary Supplement)
Probiotic Whole Grain Pasta
Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.
干预措施: whole grain pasta (Dietary Supplement)
结局指标
主要结局
Variation of fecal microbiota composition
时间窗: 12 weeks
By FISH (colony-forming unit, CFU/g). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Variation of antioxidant activity on fecal waters
时间窗: 12 weeks
Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations. Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
Variation of plasma lipids
时间窗: 12 weeks
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered.
次要结局
- Variation of serum inflammatory marker concentration(12 weeks)
- Variation of body weight(12 weeks)
- Variation of urine antioxidant marker(12 weeks)
- Variation of blood pressure(12 weeks)
- Variation of body circumferences(12 weeks)
研究者
Nicoletta Pellegrini, PhD
Associate Professor
University of Parma