Anti-obesity Effects of Metabolaid® With AMPK-activating Capacity in Overweight Subjects: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes in body Weight, using a weight scale
研究概览
简要总结
The objective of this study was to establish a formulation, containing both Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.
详细描述
AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. Anthropometric and circulating biochemical parameters were determined.
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, Care Provider)
入排标准
- 年龄范围
- 36 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants with a body mass index (BMI) from 24 to 34 kg/m2
排除标准
- •total cholesterol lower than 200 mg/dL.
- •use of prescription medication for cholesterol or hypertension.
- •presence of any obesity-related pathology.
- •hormone replacement therapy.
- •consumption of antioxidant supplements/drugs.
- •alcohol addiction.
- •women who were pregnant or lactating.
研究组 & 干预措施
Placebo Control
2 capsules per day, each with 400 mg Cellulose microcrystalline, for 8 weeks
干预措施: Placebo (Dietary Supplement)
Dietetic Supplement Group
2 Capsules per day of Metabolaid® (each capsule contains 250 mg Metabolaid®, 150 mg cellulose microcrystalline), for 8 weeks
干预措施: Metabolaid® (Dietary Supplement)
结局指标
主要结局
Changes in body Weight, using a weight scale
时间窗: At the beginning, four weeks and end of the intervention, total eight weeks.
In Kg
次要结局
- HDL Cholesterol(At the beginning, four weeks and eight weeks)
- Total Cholesterol(At the beginning, four weeks and eight weeks)
- Blood Pressure(At the beginning, four weeks and eight weeks)
- Heart rate(At the beginning, four weeks and eight weeks)
- Height, using measuring tape(At the beginning, four weeks and eight weeks)
- BMI, calculated based on Weight and Height(At the beginning, four weeks and eight weeks)
- Waist Circumference, using a measuring tape(At the beginning, four weeks and eight weeks)
- Glucose(At the beginning, four weeks and eight weeks)
- Tryglicerides(At the beginning, four weeks and eight weeks)
- LDL Cholesterol(At the beginning, four weeks and eight weeks)
研究者
María Herranz-Lopez
Assistant Professor
Universidad Miguel Hernandez de Elche