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临床试验/NCT01046968
NCT01046968已完成1 期

The Use of LeptiCore® in Reducing Fat Gain and Managing Weight Loss in Patients With Metabolic Syndrome

University of Yaounde 12 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Improvement of symptoms of metabolic syndrome

研究概览

简要总结

Metabolic syndrome is directly related to obesity. This study investigated the use of a plant based formulation to improve on the condition of people with metabolic syndrome.

详细描述

LeptiCore is a proprietary combination of various ingredients which have been shown to have properties which could be beneficial to weight loss in obese and overweight human subjects. This study evaluates the effect of Lepticore on bodyweight as well as parameters associated with obesity and metabolic syndrome.

The study was an 8 week randomized, double-blind, placebo-controlled design involving 92 obese (mean BMI>30kg/m2) participants (37 males; 55 females; ages 19-52; mean age = 30.7). The participants were randomly divided into three groups: placebo (n=30), LeptiCore formula A (low dose) (n=31) and LeptiCore formula B (high dose) (n=31). Capsules containing the placebo or active formulations were administered twice daily before meals with 300 ml of water. None of the participants followed any specific diet nor took any weight-reducing medications for the duration of the study. A total of 12 anthropomorphic and serological measurements were taken at the beginning of the study and after 2, 4, 6, and 8 weeks of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
19 Years 至 52 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI >30 kg/m2
  • Total cholesterol >200 mg/dl
  • LDL cholesterol >160 mg/dl
  • HDL cholesterol <40 mg/dl; triglycerides >150 mg/dl
  • Fasting blood glucose >100 mg/dl
  • Blood pressure >130/85 mmHg.

排除标准

  • Morbid obesity (BMI >40 kg/m2 )
  • Diabetes mellitus requiring daily insulin management
  • Pregnancy/lactation
  • Active infection
  • Systemic disease such as HIV/AIDS,
  • Use of any cholesterol-lowering medications 30 days prior to study
  • Enrollment in another clinical study within the past 6 months.

结局指标

主要结局

Improvement of symptoms of metabolic syndrome

时间窗: 8 weeks

次要结局

  • Change in weight(8 weeks)

研究者

发起方
University of Yaounde 1
申办方类型
Other

研究点 (2)

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