Effect of Consumption of Caraway on Treatment of Obesity
Клучни зборови
Апстракт
Опис
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).
Датуми
Последен пат проверено: | 03/31/2013 |
Прво доставено: | 03/25/2013 |
Поднесено е проценето запишување: | 04/14/2013 |
Прво објавено: | 04/15/2013 |
Последното ажурирање е доставено: | 04/14/2013 |
Последно ажурирање објавено: | 04/15/2013 |
Крај на датумот на започнување на студијата: | 08/31/2012 |
Проценет датум на примарно завршување: | 11/30/2012 |
Проценет датум на завршување на студијата: | 11/30/2012 |
Состојба или болест
Интервенција / третман
Dietary Supplement: caraway sample
Dietary Supplement: Placebo
Фаза
Групи за раце
Рака | Интервенција / третман |
---|---|
Experimental: caraway sample caraway sample | Dietary Supplement: caraway sample |
Active Comparator: Placebo | Dietary Supplement: Placebo |
Критериуми за подобност
Возраст подобни за студии | 20 Years До 20 Years |
Полови квалификувани за студии | Female |
Прифаќа здрави волонтери | Да |
Критериуми | Inclusion Criteria: - overweight and obese women (BMI> 25) - aged 20-55 years old - healthy subjects Exclusion Criteria: - 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 - myopathy - 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 - smoking - 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 |
Исход
Мерки на примарниот исход
1. Change in body mass index [Baseline and 12 weeks]
Секундарни мерки на исходот
1. change in all blood parameters [Baseline and 12 weeks]
2. Change in vital parameters (systolic and diastolic blood pressure and pulse rate) [Baseline and 12 weeks]
3. Change in body weight [Baseline and 12 weeks]
4. Change in anthropometric indices including waist, hip, thigh and mid-upper arm circumference (cm) [Baseline and 12 weeks]
5. Change in appetite [Baseline and 12 weeks]
6. Change in body composition including fat percentage, muscle mass, lean body mass, bone mass and water percentage [Baseline and 12 weeks]
7. Change in body weight (kg) [Baseline and 12 weeks]
8. Change in basic and active metabolic rate [Baseline and 12 weeks]
9. Change in food intake [Baseline and 12 weeks]
10. Change in urine specific gravity [Baseline and 12 weeks]