Evaluation of a Bakery Product Enriched With Fibre and L-carnitine on Cardiovascular Risk Parameters in Patients With Metabolic Syndrome: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration
研究概览
简要总结
The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients with or without metabolic syndrome.
详细描述
Conceivably, different biochemical changes in insulin-mediated signalling pathways may contribute to an impaired insulin-mediated glucose transport and metabolism that eventually results in insulin resistance and the clinical features of metabolic syndrome. According to this, both compounds -L-carnitine and dietary fiber- interacting by different mechanism of action could improve glucose homeostasis and insulin sensitivity. However, the health beneficial effects of the combination of both compounds are not shown and confirmation of the functionality of such products must be accomplished by conducting the appropriate studies intervention nutrition.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 25 and 35 Kg/m2
排除标准
- •Pregnancy or lactation
- •Kidney, liver and thyroid disease
- •History of cardiovascular or chronic inflammatory disease
- •Diabetes mellitus
- •Lipid-lowering medication
- •Triglyceride concentration > 400 mg/dl
- •Consumption of other carnitine and/or fibre-enriched foods
结局指标
主要结局
To assess changes in hydrocarbonated metabolism parameters before and after fibre+carnitine/placebo administration
时间窗: baseline and 12 weeks
Blood samples were collected in vacutainer serum separator tubes, after 12-hour overnight fasting, to analyze glucose, insulin and C-peptide concentration at baseline (after a four weeks run-in period of a healthy diet), and 12 weeks after fibre+carnitine/placebo administration. Glucose was determined using enzymatic techniques and insulin and C-peptide were measured by an enzymatic luminescence technique in an autoanalyzer. Insulin resistance was calculated by homeostasis model assessment (HOMA = (fasting insulin (μU/mL×) fasting glucose (mg/dl)/405).
次要结局
- To evaluate changes in a composite measure of inflammatory parameters before and after fibre+carnitine/placebo administration(baseline and 12 weeks)
- To evaluate changes in lipid parameters before and after fibre+carnitine/placebo administration(baseline and 12 weeks)
研究者
Antonio Hernandez Mijares
PhD, MD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana