Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEF) on Biochemical and Anthropometric Markers of Metabolic Syndrome (MS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 325
- 试验地点
- 8
- 主要终点
- HDL-cholesterol blood levels (mg/dl)
研究概览
简要总结
This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being:
- fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR
- HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).
Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either:
- Dairy BEF + egg placebo + bakery placebo
- Egg BEF + dairy placebo + bakery placebo
- Bakery BEF + dairy placebo + egg placebo
- Dairy, egg and bakery placebo
Participants will be required to consume all three of the allocated products each day for 12 weeks.
Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks.
At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects presenting with two to four diagnostic criteria for metabolic syndrome, at least one of them being elevated fasting triglycerides OR HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).
排除标准
- •subjects with five clinical criteria for metabolic syndrome
- •Regular drug therapy with impact on serum lipids;
- •Diabetes (fasting glucose > 1.26 g/L, or anti-diabetic treatment);
- •Celiac disease, lactose intolerance, allergy to milk or egg proteins;
- •Antibiotic treatment within the last 3 months;
- •Recent history of cancer or cancer treatment (less than 2 years);
- •Active or recently diagnosed intestinal malabsorption;
- •Diagnosis of organ failure
- •Familial dyslipidemia (TG ≥ 4.5 mmol/l or 400 mg/dl);
- •Illegal drug use or chronic alcoholism or smoking;
- •Intensive physical exercise (≥ 5 hour/week);
- •Consumption of nutritional supplements containing DHA, BG or AC;
- •History of allergy or intolerance to any components used in BEF;
- •Women who are pregnant or lactating;
结局指标
主要结局
HDL-cholesterol blood levels (mg/dl)
时间窗: Baseline and 12 weeks
Change from baseline in HDL-cholesterol blood levels after 12 weeks of consumption of foods
Triglycerides blood levels (mg/dl)
时间窗: Baseline and 12 weeks
Change from baseline in triglycerides blood levels after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
次要结局
- Blood glucose (mg/dl).(Baseline and 12 weeks)
- Blood pressure (mmHg)(Baseline and 12 weeks)
- Homeostasis Model Assessment (HOMA) Index levels.(Baseline and 12 weeks)
- Dna methylation levels (%).(Baseline and 12 weeks)
- Serum Hemoglobin A1c (HbA1c) levels (%)(Baseline and 12 weeks)
- Waist circumference (cm).(Baseline and 12 weeks)
- Fecal microbiota composition (analysis of principal coordinates - PCOA)(Baseline and 12 weeks)
- Fecal Short Chain Fatty Acids (parts per million).(Baseline and 12 weeks)
- Fecal metabolite levels (parts per millions).(Baseline and 12 weeks)
- Urinary food metabolite levels (parts per millions).(Baseline and 12 weeks)
研究者
Luigi Ricciardiello
Associate Professor of Gastroenterology, University of Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna