Caraway Intake as a Sustainable Dietary Practice: Impact on Overweight & Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Change in body mass index
研究概览
简要总结
This study aims to investigate the applicability of caraway (black cumin) intake on the treatment of obesity. So, a randomized placebo controlled clinical trial will be conducted to examine the applicability of caraway product in terms of safety and efficacy.
详细描述
A randomized placebo-controlled clinical trial, was done on 120 healthy overweight and obese women aged 20-55 in Iran. data were collected trough questionaires, interview and physical examination. the required parameters including anthropometric indices, body composition vital parameters (heart rate and blood pressure)and full blood parameters, were measured before and after intervention. volunteers were randomized into test and control group and were asked to consume either caraway samples or placebo during 12 intervention weeks.
the outcome measure will be assessed for both primary and secondary data from baseline through week 12 (3 months).
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
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •overweight and obese women (BMI> 25)
- •aged 20-55 years old
- •healthy subjects
排除标准
- •Pregnant and lactating women
- •Thyroid disease
- •type I or II diabetes mellitus
- •hypertension (systolic BP 140 and/or diastolic BP 90)
- •endocrine dysfunction
- •impaired liver function
- •chronic renal disease
- •cardiovascular disease
- •primary dyslipidemia
- •patients using drugs which affect on metabolism or appetite
- •a maintained weight loss in the preceding 3 months
- •meals not eaten at regular intervals
- •participation in another investigation study within the past 30 days
- •a history of alcohol or drug abuse within the past year
- •a history of sleep disorders
- •clinical depression or other psychiatric conditions
- •abnormal obese
- •allergy or sensitivity to any of the 'active' or 'placebo' product ingredients
结局指标
主要结局
Change in body mass index
时间窗: Baseline and 12 weeks
The changes in BMI from baseline at 12 weeks are measured.
次要结局
- Change in appetite(Baseline and 12 weeks)
- Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm)(Baseline and 12 weeks)
- Change in body weight(Baseline and 12 weeks)
- change in all blood parameters(Baseline and 12 weeks)
- Change in basic and active metabolic rate(Baseline and 12 weeks)
- Change in vital parameters (systolic and diastolic blood pressure and pulse rate)(Baseline and 12 weeks)
- Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage(Baseline and 12 weeks)
- Change in urine specific gravity(Baseline and 12 weeks)
- Change in body weight (kg)(Baseline and 12 weeks)
- Change in food intake(Baseline and 12 weeks)