Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Variation of plasma lipids
研究概览
简要总结
The aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial.
详细描述
Epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health. Among the dietary patterns, it has been showed that the adherence to a plant-based diet, i.e. Mediterranean diet, may have a pivotal role in promoting a health longevity and counteracting cardiovascular, neurological and cancer-related diseases. In fact, the abundant consumption of fruit, vegetables, cereals and pulses leads to a high intake of vegetable proteins, unsaturated fatty acids, minerals, vitamins, fibre and bioactive compounds which may have anti-inflammatory, antioxidant, anti-atherosclerotic, hypocholesterolemic and antimicrobial activities. In particular, there is a growing interest for valorization of pulses, among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal. Lupins are traditional legumes of the Mediterranean basin, and they represent a good source of bioactive peptides, soluble fibre and minerals. Different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure, reduction of blood glucose, cholesterol, triglycerides and uric acid.
Nevertheless, there is still a lack of information regarding the effects of the consumption of whole lupins, and in particular in one of the most sold forms, as in brine.
In this parallel randomized controlled trial, 60 healthy volunteers were randomly allocated for a 4-week consumption of:
- Active comparator arm: 30 grams per week of lupins in brine;
- Experimental arm: 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat, processed meat and/or cheese;
At baseline and after 4 weeks of dietary intervention, subjects were visited in medical facility and asked to provide blood, urine, saliva, feces for the evaluation of:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI included between 18.5 and 29.9 kg/m2;
- •Omnivorous diet;
- •Consumption of more than 6 servings of meat, processed meat and/or cheese;
排除标准
- •Antibiotic treatment within 3 months prior the dietary intervention;
- •Chronic diseases
- •Surgeries
- •Pregnant or lactating
结局指标
主要结局
Variation of plasma lipids
时间窗: 4 weeks
Measure of plasma concentrations (mg/dL) of triglycerides before and after dietary intervention. 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 anthropometrics or metabolic marker cut-off value was applied, and statistical differences of the primary outcome have been considered.
次要结局
- Variation of anthropometric parameters(4 weeks)
- Variation of blood pressure parameters(4 weeks)
- Variation of blood glucose(4 weeks)
- Variation of blood insulin(4 weeks)
- Variation of C-peptide(4 weeks)
- Variation of blood lipid-related parameters(4 weeks)
- Variation of transaminase parameters(4 weeks)
- Variation of inflammatory parameters(4 weeks)
- Variation of citokine and interleukine parameters(4 weeks)
- Variation of urinary inflammatory parameters(4 weeks)
- Variation of genetic and epigenetic expression of inflammatory mediators parameters(4 weeks)
- Variation of gut microbiota profile parameters(4 weeks)
研究者
Mauro Serafini
Professor
University of Teramo