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临床试验/NCT01360957
NCT01360957撤回不适用

Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women

Shahid Beheshti University of Medical Sciences0 个研究点开始时间: 2011年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Body water (percentage)

研究概览

简要总结

The purpose of this clinical trial is to study the therapeutic effect of black cumin water extract (Nigella sativa L.) on obesity and overweight

详细描述

The worldwide prevalence of obesity has reached epidemic proportions mostly in low-income and transitional than in industrialized countries. Changes in dietary habits and sedentary lifestyles are known to be associated with changes in health and increased prevalence of chronic diseases in the population. The need to promote healthy nutrition for the population must be pursued vigorously, as the escalation of nutrition-related chronic degenerative diseases - once an urban phenomenon - has now spread to the rural population at an alarming rate. During the past decades efficacious strategies have been developed for prevention of these diseases. These strategies involve general lifestyle changes, which include, healthy diet, optimal weight, physical activity, moderate or no alcohol consumption, control of diabetes mellitus and in particular, treatment of obesity. Although the global market for satiety, fat burning and other weight management remedies has been grown, the awareness of the benefits of weight management ingredients is neither sufficient nor clearly perceived by consumer. Subsequently, the opportunities for scientifically-substantiated weight management ingredients regarding the natural and herbal dietary pattern are impressive.

The seed of Nigella sativa (black cumin) is one of the most common traditional herbs for weight loss in the Middle East which is usually used as a spice as well as traditional medicine to treat a variety of health conditions especially inflammatory diseases and obesity.

Furthermore, many of the components present in black cumin including polyphenols have been attributed to have anti-inflammatory and anti-obesity effect which further supports our hypothesis.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Being Obese

排除标准

  • Having heart disease or renal disease
  • using drugs influencing metabolism and appetite

结局指标

主要结局

Body water (percentage)

时间窗: 0 and 12 weeks

Change from Baseline in body water at 12 weeks

HR (heart rate)

时间窗: 0 and 12 weeks

Change from Baseline in heart rate at 12 weeks

Bone mass

时间窗: 0 and 12 weeks

Change from Baseline in bone mass at 12 weeks

AMR (active metabolic rate)

时间窗: 0 and 12 weeks

Change from Baseline in AMR at 12 weeks

Fat mass (percentage)

时间窗: 0 and 12 weeks

Change from Baseline in fat mass at 12 weeks

BP (blood pressure)

时间窗: 0 and12 weeks

Change from Baseline in Systolic Blood Pressure at 12 weeks

Fat free mass (percentage)

时间窗: 0 and 12 weeks

Change from Baseline in fat free mass at 12 weeks

BMR (basic metabolic rate)

时间窗: 0 and12 weeks

Change from Baseline in BMR at 12 weeks

次要结局

  • BMI (body mass index)(0 and 12 weeks)
  • Wrist circumference(0 and 12 weeks)
  • Changes in appetite as measured by a 10-point visual analog scale (VAS)(0 and 12 weeks)
  • WHR (waist to hip ratio)(0 and 12 weeks)
  • MUAC (mid upper arm circumference)(0 and 12 weeks)

研究者

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