Effect of Intake of Dehydrated Nopal Powder From Highly Mature Cladodes (Opuntia Ficus-indica) on the Lipid Profile of Overweight or Obese Adults. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Blood lipid levels
研究概览
简要总结
Background: Opuntia ficus-indica is a plant from the cactus family (Cactaceae) that is widespread and of great economic importance in Mexico. It has been consumed as food since pre-Hispanic times and is currently considered a nutraceutical. In this study, the effect of consumption of dehydrated nopal powder from highly mature cladodes (Opuntia ficus-indica) on the lipid profile of overweight or obese patients diagnosed with dyslipidemia was investigated. Methods: A 3-month prospective clinical trial was conducted in 35 overweight or obese patients with dyslipidemia. The sample was divided into three groups with a daily intake of 30 g of dietary fiber: Group I received 5 g of dehydrated Opuntia ficus-indica cladodes plus the standard normocaloric diet for dyslipidemia, Group II received 15 g plus the diet, and Group III followed only the diet.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with dyslipidemia, confirmed by lipid meas-urement in blood chemistry
- •overweight or obesity
- •A cardiovascular risk factor associated with abdominal obesity
排除标准
- •Patients with a suspected diagnosis of primary dyslipidemia
- •Hypertension
- •Thyroid disease were excluded from the study
- •Patients with complex or severe disease such as heart failure, liver or kidney disease
- •Pregnant or lactating women
- •Indidividuals taking lipid-modifying drugs or hormone replacement therapy - Patients with gastrointestinal problems and deficiencies
结局指标
主要结局
Blood lipid levels
时间窗: From enrollment to the end of treatment at 12 weeks
A blood sample (3 ml) was taken from the patients after fasting for 12 hours, then prepared for subsequent analysis by an enzymatic method. The Clinical 50 VWR cen-trifuge ® was used for sample preparation and the Roche Cobas C 111 ® kit for lipid analysis of the samples. These analyses were performed in duplicate. Comparison of supplementation with dehydrated nopal powder from highly mature cladodes, by group, in initial and final values of the lipid profile: Total cholesterol; LDL, Low-density lipoproteins; HDL, High-density lipoproteins; TGL, Tri-glycerides.
次要结局
未报告次要终点
研究者
Maria de los Angeles Aguilera Barreiro
Director and Principal Investigator
Universidad Autónoma de Querétaro